BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MSD - UNKNOWN IMPLANT

    MDR report key: 824348 · Received February 27, 2007

    Report

    Report Number
    1030489-2007-00053
    Event Type
    Injury
    Date Received
    February 27, 2007
    Report Date
    January 29, 2007
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS IN REFERENCE TO A VOLUNTARY MEDWATCH SUBMITTED BY A USER FACILITY. WE ARE UNABLE TO DETERMINE THE "SUSPECTED MEDICAL DEVICE", HOWEVER, THE FOLLOWING DEVICES WERE USED: ITEM# 75446545 LOT# W05F4394 X 2, ITEM# 75446535 LOT# W04K6634 X 1, ITEM# 75446535 LOT# W05G0155 X 1, ITEM# 2961026 LOT# KR33 X 1, ITEM# 811-323 LOT# W05F3223 X 1, MULTI-AXIAL 30 OFFSET SCREWS X 4. DEVICE HAS NOT BEEN RETURNED TO THE MFR TO HOSPITAL POLICY; THEREFORE, PRODUCT EVAL IS NOT POSSIBLE. WE ARE UNABLE TO VERIFY PRODUCT PROBLEM DUE TO THE LACK OF INFO INCLUDED IN THE VOLUNTARY MEDWATCH . IN ADD'L WE ARE UNABLE TO DETERMINED IF THE SURGERY (REVISION) IS DUE TO OUR PRODUCTS. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    DATE OF IMPLANT: IN 2005. IT WAS REPORTED ON A VOLUNTARY MEDWATCH BY A USER FACILITY THAT A PATIENT UNDERWENT A L5- S1 PLIF PROCEDURE, DUE TO REPORTED COMPLAINTS OF BACK AND RIGHT RADICULAR PAIN. APPROXIMATELY 14 MONTHS POST-OP, PATIENT CONTINUES TO COMPLAIN OF PAIN, UNRESPONSIVE TO MULTIPLE ATTEMPTS OF CONSERVATIVE TREATMENT. SHORTLY THEREAFTER, PATIENT UNDERGOES A REVISION SURGERY TO REMOVE AND REPLACE THE HARDWARE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MSD - UNKNOWN IMPLANT UNKNOWN IMPLANT KWP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention