BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL-HOLDER F/PLIVIOS REVOLUTION SST

    MDR report key: 3190953 · Received June 26, 2013

    Report

    Report Number
    8030965-2013-02753
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    January 26, 2011
    Report Date
    February 7, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES. THE INVESTIGATION OF THE COMPLAINT INSTRUMENT HAS SHOWN THAT INDEED ONE SCREW WAS MISSING OR HAS FALLEN OFF. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS REPORTED PROBLEM. WE DO PRESUME THOUGH, THAT THE SCREW GOT LOST DURING THE CLEANING STERILIZING PROCESS. THE INSTRUMENT WAS SENT TO OUR REPAIR DEPARTMENT. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO DISCREPANCIES TO THE SPECIFICATIONS WERE FOUND. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    THE LOCKING SCREW OF THE FRONT PART IS LOOSENING AND IT WAS LOST DURING CLEANING. THIS IS 1 OF 1 REPORT FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290292 IMPL-HOLDER F/PLIVIOS REVOLUTION SST LXH SYNTHES GMBH 3211707

    Patients

    Seq Age Sex Outcome Treatment
    1