BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 11517590 · Received March 18, 2021

    Report

    Report Number
    3006742481-2021-00003
    Event Type
    Malfunction
    Date Received
    March 18, 2021
    Date of Event
    February 11, 2021
    Report Date
    March 17, 2021
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    KWI
    UDI-DI
    00841506100043
    PMA / PMN Number
    K172688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS INDICATED THAT THE PRODUCT WILL BE RETURNED TO US FOR INVESTIGATION, BUT IT HAS NOT BEEN RETURNED YET. THE INVESTIGATION IS IN PROCESS, HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THE TIME OF FILING THIS REPORT. THE INSTRUCTION FOR USE STATE: THE LOCK SCREW PACKAGED WITH THE RADIAL HEAD MUST BE INSTALLED AND FULLY TIGHTENED TO FIX THE RADIAL HEAD TO THE RADIAL STEM. IF THE LOCK SCREW IS NOT ATTACHED AND/OR FULLY SECURED, THE RADIAL HEAD MAY LOOSEN AND/OR DISCONNECT FROM THE RADIAL STEM, CAUSING SOFT TISSUE IRRITATION AND/OR DEVICE FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY 2 YEARS POST IMPLANTATION DUE TO LOOSENING OF THE PRODUCT. THE SCREW HAD BACKED OUT FROM THE RADIAL HEAD CAUSING IT TO BECOME LOOSE. THE HEAD AND SCREW WERE REPLACED ONTO THE EXISTING STEM. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFORMATION AND/OR THE EXPLANTED PRODUCT TO BE RETURNED BUT IS UNAVAILABLE AT THIS TIME OF FILING THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410432 SKELETAL DYNAMICS ALIGN RADIAL HEAD SYSTEM KWI SKELETAL DYNAMICS ALIGN Radial Head & Lock Screw, 24mm AN1806008 00841506100043

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention