BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI POLYAXIAL PEDICLE SCREW 6.5MM X 50MM

    MDR report key: 2220779 · Received August 23, 2011

    Report

    Report Number
    2027467-2011-00019
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 9, 2011
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    KWP
    PMA / PMN Number
    K033090
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION CANNOT BE CONDUCTED. THE BROKEN SCREW REMAINS ANCHORED IN THE PATIENT WHERE ORIGINALLY POSITIONED. CORRESPONDENCE DATED (B)(4) 2011 INDICATES THE SURGEON IS NOT PLANNING TO REMOVE THE FRACTURE DEVICE. BECAUSE MULTIPLE SCREWS WERE USED IN THE CASE AND THE SUSPECT DEVICE WILL NOT BE REMOVED, THE EXACT LOT NUMBER OF THE FRACTURED DEVICE CANNOT BE DETERMINED. THE THREE LOTS LISTED BELOW ARE CURRENTLY IMPLANTED IN THE PATIENT. PART NUMBER: 62065-50, LOT NUMBER: 623468, MANUFACTURED DATE: 5/01/2009; 62065-50, 623996, 5/13/2009; 62065-50, 626602, 9/21/2009. THE SUPPLIED INSTRUCTIONS FOR USE (INS-025) READS AS FOLLOWS: POSSIBLE ADVERSE EFFECTS SECTION# 1; INITIAL OR DELAYED LOOSENING, DISASSEMBLY, BENDING, DISLOCATION AND/OR BREAKAGE OF DEVICE COMPONENTS. POSTOPERATIVE MANAGEMENT SECTION# 6; THE ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM IMPLANTS ARE DESIGNED AND INTENDED AS TEMPORARY FIXATION DEVICES. THE DEVICES SHOULD BE REMOVED AFTER COMPLETE HEALING HAS OCCURRED. DEVICES, WHICH ARE NOT REMOVED AFTER SERVING THEIR INTENDED PURPOSE MAY BEND, DISLOCATE, OR BREAK AND/OR CAUSE CORROSION, LOCALIZED TISSUE REACTION, PAIN, INFECTION, AND/OR BONE LOSS DUE TO STRESS SHIELDING. COMPLETE POSTOPERATIVE MANAGEMENT TO MAINTAIN THE DESIRED RESULTS SHOULD FOLLOW IMPLANT REMOVAL SURGERY.

    Description of Event or Problem · 1

    AN INTERNATIONAL CUSTOMER ((B)(6)) REPORTED THAT ON (B)(6) 2011 A PATIENT CAME IN FOR A REGULAR SCHEDULED FOLLOW-UP VISIT. X-RAYS TAKEN AT THE TIME REVEALED A POLYAXIAL SCREW HAD BROKEN IN THE L3 LUMBAR VERTEBRAE. ADDITIONAL CORRESPONDENCE INDICATED THE SURGEON IS NOT PLANNING TO REMOVE THE FRACTURED DEVICE. THE ZODIAC SPINAL FIXATION SYSTEM HAD ORIGINALLY BEEN IMPLANTED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI POLYAXIAL PEDICLE SCREW 6.5MM X 50MM KWP, MNI, MNH KWP ALPHATEC SPINE INC 62065-50

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other