BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 5643367 · Received May 10, 2016

    Report

    Report Number
    1030489-2016-01345
    Event Type
    Injury
    Date Received
    May 10, 2016
    Report Date
    April 12, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT APPROVED FOR SALE IN US BUT A SIMILAR PRODUCT WITH CATALOG # 8365359 AND 510K# K090740 IS APPROVED FOR SALE IN US. NEITHER THE PRODUCT NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE DEFINITIVE CAUSE OF EVENT CANNOT BE DETERMINED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WITH L4-5 SPONDYLOLISTHESIS UNDERWENT L4-5 POSTERIOR LUMBAR INTERBODY FUSION .ON AN UNKNOWN DATE POST-OP, IT WAS FOUND THAT THE PEDICLE SCREW INVADED INTO THE SPINAL CANAL. DURING SURGERY, THE DIRECTION OF PEDICLE SCREW SEEMED TO HAVE NO PROBLEM UNDER THE X-RAY. THE PATIENT COMPLAINED OF LOWER EXTREMITIES PAIN AFTER THE SURGERY. PATIENT COMPLICATIONS WERE REPORTED. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2016 TO REPLACE PEDICLE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298364 TSRH SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention