BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM

    MDR report key: 8483029 · Received April 4, 2019

    Report

    Report Number
    0009610622-2019-00138
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 20, 2019
    Report Date
    May 6, 2019
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    UDI-DI
    04546540202482
    PMA / PMN Number
    K032244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CONCOMITANT AND DID NOT CONTRIBUTE TO THE REPORTED FAILURE. IF ANY ADDITIONAL INFORMATION IS PROVIDED INDICATING OTHERWISE, THE INVESTIGATION WILL BE UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GAMMA3 U-LAG SCREW SURGERY ON (B)(6) 2019. AFTER THE SURGERY, THE CUTOUT OF U-LAG SCREW AND THE BENDING OF U-BLADE WERE CONFIRMED. THEN GAMMA3 EXTRACTION AND REVISION TO THA WAS PERFORMED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, ADDITIONAL INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GAMMA3 U-LAG SCREW SURGERY ON (B)(6) 2019. AFTER THE SURGERY, THE CUTOUT OF U-LAG SCREW AND THE BENDING OF U-BLADE WERE CONFIRMED. THEN GAMMA3 EXTRACTION AND REVISION TO THA WAS PERFORMED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277774 LOCKING SCREW, FULLY THREADED T2 TIBIA Ø5X35 MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K099DC8 04546540202482

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention