BEUDAMED
    FDA Adverse Event Other Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 1080322 · Received July 18, 2008

    Report

    Report Number
    1030489-2008-00358
    Event Type
    Other
    Date Received
    July 18, 2008
    Report Date
    June 23, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IMPLANT DATE: UNKNOWN. IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE USING INTERBODY DEVICE AND POSTERIOR FIXATION. APPROXIMATELY ONE MONTH POST-OP, IT WAS FOUND THAT THE SCREW WAS IMPLANTED INCORRECTLY. A REVISION SURGERY IS PLANNED TO REVISE THE IMPLANTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1