BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10299818 · Received July 20, 2020

    Report

    Report Number
    3006742481-2019-00001
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    August 22, 2019
    Report Date
    September 16, 2019
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HRS
    UDI-DI
    00841506101675
    PMA / PMN Number
    K182492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DECLINED TO FOLLOW POST-SURGICAL PROCEDURES GOING AGAINST THE IFU WHICH STATES "THE PATIENT SHOULD BE INFORMED ABOUT THE IMPORTANCE OF FOLLOWING THE POST-OPERATIVE REHABILITATION PRESCRIBED IN ORDER TO FULLY UNDERSTAND THE POSSIBLE LIMITATIONS IN ACTIVITIES OF DAILY LIVING. THE PATIENT MUST BE WARNED THAT FAILURE TO FOLLOW POSTOPERATIVE CARE INSTRUCTIONS MAY CAUSE THE IMPLANT OR TREATMENT TO FAIL." THE PATIENT DID NOT FOLLOW THOSE PROCEDURES AND REMAINED ACTIVE WITHIN THE 6 WEEKS POST OP PERIOD. ALL MANUFACTURING AND INSPECTIONS WERE CONDUCTED WITHIN SPECIFICATION. THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A DEFINITIVE CONCLUSION AS TO SAY THAT THIS WAS A PRODUCT ISSUE.

    Description of Event or Problem · 1

    DOCTOR PERFORMED A GEMINUS SURGERY ON A (B)(6) MALE ON THE RIGHT WRIST. WHEN PATIENT RETURNED FOR 6 WEEKS FOLLOW UP, X-RAY IMAGING SHOWED BROKEN SCREWS ON THE DISTAL PORTION OF THE PLATE. PATIENT REFUSED FOLLOW UP PROTOCOLS AND REMAINED ACTIVE WITHIN THE 6-WEEK POST-OP PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763959 SKELETAL DYNAMICS GEMINUS VOLAR DISTAL RADIUS PLATE HRS SKELETAL DYNAMICS GEMINUS Volar Distal Radius Plate, Wide, 4 Hole, Right 00841506101675

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other