BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROX-HUMERAL LOCK-PL 3.5 5HO TI

    MDR report key: 3031430 · Received April 2, 2013

    Report

    Report Number
    8030965-2013-01328
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 6, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTW
    PMA / PMN Number
    K011815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE FAILURE OF THE INVESTIGATED PROXIMAL HUMERUS PLATE WAS DUE TO DYNAMIC BENDING WHICH LED TO THE MATERIAL FATIGUE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES, THE CONCLUSION IS THAT THE INVESTIGATED IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RECEIVED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) INDICATED A HOSPITAL IN THE (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH PROXIMAL HUMERAL LOCKING PLATE ON AN UNKNOWN DATE. THE PLATE BROKE ON AN UNKNOWN DATE AT THE LEVEL OF THE SECOND HOLE IN THE SHAFT. PLATE WAS REMOVED ON AN UNKNOWN DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134604 PROX-HUMERAL LOCK-PL 3.5 5HO TI KTW SYNTHES GMBH 2488983

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention