BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLATE

    MDR report key: 15293376 · Received August 25, 2022

    Report

    Report Number
    3006742481-2022-00007
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 24, 2022
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HSB
    UDI-DI
    00841506102153
    PMA / PMN Number
    K172688
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT IS A 60-YEAR-OLD RIGHT-HAND-DOMINANT MALE. SURGEON REPORTED THAT THE PATIENT WAS NON-COMPLIANT AND DID NOT FOLLOW POST-IMPLANTATION INSTRUCTIONS. THE PATIENT OFTEN PLAYED HIS GUITAR, MOWED HIS LAWN, AND PRIOR TO THE REVISION SURGERY GOT INTO A PHYSICAL ALTERCATION WHICH RESULTED IN A THIRD METACARPAL BASE FRACTURE. THIS FAILURE DOES NOT APPEAR TO BE DUE TO A SKELETAL DYNAMICS DEVICE MALFUNCTION. THE PATIENT WAS KNOWN TO BE INVOLVED IN STRENUOUS PHYSICAL ACTIVITIES DURING RECOVERY WHICH LIKELY AFFECTED THE SITE'S POTENTIAL TO FUSE AND CAUSED THE METACARPAL SCREW TO BACK OUT.

    Description of Event or Problem · 0

    THE SURGEON NOTICED THE DISTAL SCREW WAS BACKING OUT OF THE MEDULLARY ROD IN THE 3RD METACARPAL DURING A FOLLOW-UP VISIT THREE MONTHS POST-IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344726 IMPLATE WRIST ARTHRODESIS NAIL SYSTEM HSB SKELETAL DYNAMICS IMPLATE Nail, Metacarpal, Mini 00841506102153

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention