BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_KIE_PRODUCT

    MDR report key: 3932138 · Received July 14, 2014

    Report

    Report Number
    0009610622-2014-00328
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 19, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DETAILS DISTAL LOCKING SCREW_LONG. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED ISSUE WAS CONFIRMED VIA X-RAYS. THE LOCKING SCREWS WERE CLASSIFIED AS PRIMARY PRODUCTS DURING INVESTIGATION. AN INVESTIGATION OF THE IMPLANTS AND A REVIEW OF THE DHR WERE NOT POSSIBLE BECAUSE NEITHER THE IMPLANTS, NOR THE LOOT CODES WERE PROVIDED. THE PROVIDED X-RAYS CONFIRMED THE REPORTED EVENT: BOTH DISTAL LOCKING SCREWS ARE NO LONGER PLACED IN THEIR ORIGINAL HOLES AND WERE MIGRATED TOWARDS LATERAL; THE NAIL AND SCREWS ARE DISPLACED TOWARDS DISTAL. THE X-RAYS AND PATIENT INFORMATION WERE EVALUATED BY A MEDICAL EXPERT: THE PATIENT HAS A POOR BONE QUALITY, THE CORTICALIS IS LIKE AN ¿EGGSHELL¿; THE PATIENT HAS AN ADVANCED OSTEOPOROSIS. THE FRACTURE IS A COMPLICATED SPIRAL FRACTURE; NONE-WEIGHT BEARING TREATMENT WOULD HAVE BEEN RECOMMENDED. THE SCREWS CUT OUT AND MIGRATED DUE TO AN INADEQUATE HIGH LOAD BEARING POSTOPERATIVELY. THE IFU INCLUDES THAT WEIGHT BEARING, POOR BONE QUALITY AND OSTEOPOROTIC BONE CAN LEAD TO LOOSENING OF THE IMPLANTS. THE CASE IS CAUSED BY PATIENT CONDITIONS. NO NON-CONFORMITY IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED VIA THE SALES REP THAT DISTAL SCREWS ALLEGEDLY MIGRATED OUT OF THE FEMUR AND NAIL.

    Description of Event or Problem · 1

    THE CUSTOMER HAS REPORTED VIA THE SALES REP THAT DISTAL SCREWS ALLEGEDLY MIGRATED OUT OF THE FEMUR AND NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409395 UNKNOWN_KIE_PRODUCT IMPLANT HWC STRYKER TRAUMA KIEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention