BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO

    MDR report key: 3171558 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02874
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    December 14, 2010
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K083694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THERE IS EVIDENCE OF HIGH MECHANICAL LOAD (FATIGUE) LEADING TO THE BREAKAGE OF THE PLATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PLATE WAS ORIGINALLY IMPLANTED DURING A CORRECTIVE OSTEOTOMY PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2010. THE PLATE BROKE POST-OPERATIVELY ON AN UNDISCLOSED DATE. REPORTEDLY, THERE WAS VERY LITTLE RADIOGRAPHIC EVIDENCE OF BONE HEALING AT THE OSTEOTOMY SITE ON RE-XRAY OF THE PATIENT FOLLOWING IMPLANT BREAKAGE. ACCORDING TO THE SURGEON, THE PATIENT REPORTED NO FALL ONTO THIS AFFECTED WRIST OR ANY HIGH LOADINGS THAT COULD BE EXPECTED TO PRECIPITATE AN IMPLANT FAILURE OF THIS NATURE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272591 VA-LCP-2-COLUMN DRP2.4 VOLAR R SHAFT 3HO HRS SYNTHES GMBH 3378908

    Patients

    Seq Age Sex Outcome Treatment
    1