BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 12291240 · Received August 6, 2021

    Report

    Report Number
    3006742481-2021-00007
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    July 8, 2021
    Report Date
    August 6, 2021
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HRS
    UDI-DI
    00841506105789
    PMA / PMN Number
    K171590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT PART IS NOT EXPECTED TO BE RETURNED FOR REVIEW/INVESTIGATION. DEVICE PART NUMBER WAS GIVEN, AND A THOROUGH REVIEW OF DEVICE RECORDS WAS CONDUCTED AND CONCLUDED TO BE WITHIN SPECIFICATIONS. SEVERAL ATTEMPTS WERE MADE TO GET MORE INFORMATION BUT WAS UNSUCCESSFUL. BASED ON THE LIMITED INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS REQUIRED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN HPS FRACTURE SURGERY AND HAD A TRICEPS AVULSION POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1185256 SKELETAL DYNAMICS PROXIMAL ULNA PLATE HRS SKELETAL DYNAMICS Proximal Ulna Plate, 73mm, Left DJ2009036 00841506105789

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other