BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYN-LOCK-SCR Ø5 SELF-TAP L36 COCRMO

    MDR report key: 3101791 · Received May 9, 2013

    Report

    Report Number
    2520274-2013-02458
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K110592
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4).  REPORT RECEIVED INDICATES THE MEASURABLE DIMENSIONS WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. THE EXAMINATION OF THE RAW-MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. NO PRODUCT FAULT COULD BE DETECTED. AS MENTIONED FROM THE SURGEON IT WAS DUE TO A SUSPECTED NON UNION FROM AN INFECTION. ALL RETURNED ARTICLE ARE INTACT, THEREFORE WE ARE NOT ABLE TO DETERMINE ANY CAUSE WHICH MAY HAVE LEAD TO THIS REVISION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE EVENT DATE WAS ADDED IN ERROR IN THE INITIAL MEDWATCH. (B)(4)

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013, A LOCKING COMPRESSION PLATE (LCP) WAS IMPLANTED INTO A PATIENT. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH INFECTION AND A SUSPECTED NON-UNION. THE PLATE WAS REMOVED ON (B)(6) 2013. AN EXTERNAL FIXATOR WAS APPLIED FOLLOWING REMOVAL. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204598 DYN-LOCK-SCR Ø5 SELF-TAP L36 COCRMO HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention