BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYN-LOCK-SCR Ø5 SELF-TAP L32 COCRMO

    MDR report key: 3101713 · Received May 9, 2013

    Report

    Report Number
    8030965-2013-02140
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    SYNTHES GMBH
    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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE HISTORY REVIEW FOR THIS LOT HAS BEEN REQUESTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION IS ONGOING.

    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

    THE EVENT DATE WAS ADDED IN ERROR IN THE INITIAL MEDWATCH. IT SHOULD HAVE BEEN LEFT BLANK BECAUSE IT IS UNKNOWN WHEN THE PATIENT EXPERIENCED THE INFECTION

    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 2 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202562 DYN-LOCK-SCR Ø5 SELF-TAP L32 COCRMO HWC SYNTHES GMBH 7771387

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention