Events

Retiro De Equipo (Recall) de Device Recall Capless Li Pedicle Screw System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por X Spine Systems Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    51956
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1694-2009
  • Fecha de inicio del evento
    2009-03-24
  • Fecha de publicación del evento
    2009-08-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81734
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Orthosis, spondyloisthesis spinal fixation - Product Code MNH
  • Causa
    A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the capless li screw construct. the screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. the screw ball on the screw was manufactured out of tolerance (undersized).
  • Acción
    X Spine Systems Inc. issued advisory notices in March 2009 to Consignees notifying them of the problem and requesting all affected product be returned to the firm. The firm also conducted telephone calls and emails for the return of the product. For further information, contact X Spine Systems Inc. at 1-937-847-8400 extension 115.

Device

Device Recall Capless Li Pedicle Screw System
  • Modelo / Serial
    Product Numbers: 71088, 71692, 71708, 71750, 71761, 71781, 71807, 71849, 71881, 71090, 71693, 71709, 71751, 71762, 71787, 71808, 71850, 71882, 71092, 71694, 71710, 71752, 71763, 71789, 71809, 71851, 71885, 71682, 71695, 71711, 71753, 71764, 71791, 71810, 71857, 71886, 71686, 71696, 71712, 71755, 71765, 71793, 71811, 71858, 71889, 71687, 71698, 71716, 71756, 71766, 71795, 71813, 71859, 71893, 71688, 71700, 71746, 71757, 71767, 71797, 71814, 71873, 71894, 71689, 71701, 71747, 71758, 71768, 71799, 71815, 71874, 71896, 71690, 71705, 71748, 71759, 71769, 71801, 71816, 71877, 71897, 71691, 71707, 71749, 71760, 71780, 71806, 71817, 71878, 71899, 71900, 71937, 71957, 73417, 73427, 73440, 73453, 73470, 74073, 71903, 71939, 72184, 73418, 73428, 73441, 73454, 73471, 74097, 71904, 71940, 72419, 73419, 73429, 73445, 73455, 73472, 74098, 71907, 71943, 73409, 73420, 73430, 73446, 73456, 73760, 74099, 71908, 71944, 73411, 73421, 73431, 73447, 73464, 73761, 74100, 71911, 71947, 73412, 73422, 73433, 73448, 73465, 73762, 74101, 71912, 71948, 73413, 73423, 73435, 73449, 73466, 73763, 74102, 71915, 71952, 73414, 73424, 73437, 73450, 73467, 73886, 74103, 71916, 71953, 73415, 73425, 73438, 73451, 73468, 74047, 74104, 71936, 71956, 73416, 73426, 73439, 73452, 73469, 74072, 74105, 74107, 74125, 74143, 74293, 74305, 75280, 75297, 75307, 75317, 74108, 74127, 74144, 74294, 74306, 75282, 75299, 75308, 75318, 74109, 74129, 74285, 74295, 74307, 75283, 75300, 75309, 75319, 74110, 74131, 74286, 74296, 74432, 75284, 75301, 75310, 75320, 74111, 74132, 74287, 74299, 74987, 75285, 75302, 75311, 75321, 74112, 74134, 74288, 74300, 74991, 75287, 75303, 75312, 75322, 74116, 74135, 74289, 74301, 75248, 75289, 75304, 75313, 75323, 74119, 74137, 74290, 74302, 75273, 75291, 75305, 75314, 75324, 74121, 74139, 74291, 74303, 75276, 75293, 75305, 75315, 75333, 74123, 74141, 74292, 74304, 75278, 75295, 75306, 75316, 75334, 75335, 75355, 75376, 76369, 76536, 76593, 76602, 76613, 76639, 75336, 75358, 75377, 76370, 76537, 76593, 76603, 76614, 76640, 75337, 75360, 75379, 76372, 76538, 76594, 76605, 76615, 76642, 75338, 75362, 75382, 76374, 76540, 76595, 76606, 76616, 76737, 75344, 75364, 75384, 76375, 76542, 76596, 76607, 76618, 77253, 75346, 75365, 75386, 76376, 76588, 76597, 76608, 76619, 77260, 75346, 75367, 75588, 76377, 76589, 76598, 76609, 76621, 77261, 75350, 75370, 75798, 76406, 76590, 76599, 76610, 76629, 77262, 75351, 75372, 75802, 76407, 76591, 76600, 76611, 76630, 77263, 75353, 75375, 76139, 76534, 76592, 76601, 76612, 76638, 77264, 77265, 77811, 77852, 79382, 77266, 77815, 78174, 77267, 77817, 78175, 77270, 77820, 78176, 77322, 77823, 78518, 77647, 77851 and 79040.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- Including states of AZ, CA, CO, FL, ID, IN, MO, MS, NV, OK, TN, TX, UT and WY and countries of Spain, South Africa and the United Kingdom.
  • Descripción del producto
    Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. || The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft.
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Dirección del fabricante
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Empresa matriz del fabricante (2017)
    X-Spine Systems, Inc
  • Source
    USFDA