BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA LOCKSCR Ø2.4 SELF-TAP L24 TAN

    MDR report key: 3506739 · Received December 9, 2013

    Report

    Report Number
    2520274-2013-07547
    Event Type
    Injury
    Date Received
    December 9, 2013
    Report Date
    November 11, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PMA/510(K): ADDITIONAL 510(K) #: K100776. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING REVIEW WAS NOT CONDUCTED A LOT NUMBER WAS NOT PROVIDED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION: BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, IT CAN BE CONCLUDED THAT THE IMPLANTS WERE SUBJECTED TO DYNAMIC BENDING LOADS. CONSTANTLY ALTERNATING BENDING LOADS LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE SCREWS THE VA LOCKING SCREW COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD / FATIGUE FAILURE. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE, TOO. NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2013; DURING THE SURGERY ON (B)(6) DURING THE IMPLANT REMOVAL OF VA-LCP 2CP AFTER OSTEOTOMY OF DISTAL RADIUS DUE TO FAILURE (BREAKAGE) OF THREE VA-LCP LOCKING HEAD SCREWS 2.4MM. IT WAS REPORTED THAT THE PLATE AND SCREWS WERE REMOVED COMPLETELY. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635842 VA LOCKSCR Ø2.4 SELF-TAP L24 TAN HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention