BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 1210752 · Received October 23, 2008

    Report

    Report Number
    1030489-2008-00586
    Event Type
    Injury
    Date Received
    October 23, 2008
    Report Date
    September 24, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K042789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTS REMAIN IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE PRODUCTS IN USE ARE LOT W05K3865, W06E0149, W06E3647, W07E5452; LOT W07E5464; LOT W05K2159, W07B3602, AND W07D4373. DEVICE HISTORY RECORDS THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE USING POSTERIOR FIXATION AT C5 TO T3 AND T11 TO L3. AT UNKNOWN TIME POST-OP, THE PATIENT DEVELOPED NUMBNESS IN HANDS. THE SURGEON BELIEVED THAT THE SCREW AT CERVICAL LEVEL MIGHT BE PLACED INCORRECTLY. THE REVISION SURGERY IS NOT PLANNED AT THIS TIME BECAUSE IT WAS REPORTED THAT THE PATIENT'S SYMPTOM WAS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEX RECONSTRUCTION SYSTEM BONE SCREW KWP WARSAW ORTHOPEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1