BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 130°

    MDR report key: 8483028 · Received April 4, 2019

    Report

    Report Number
    0009610622-2019-00135
    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
    04546540375834
    PMA / PMN Number
    K034002
    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
    277772 LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø10X280MM X 130° ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K0AECDA 04546540375834

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention