BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY RETAINER

    MDR report key: 3021478 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-01158
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    February 23, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE DEVICE WAS RETURNED BECAUSE IT WAS NOT WORKING CORRECTLY. THE PRODUCT WAS RECEIVED AT SERVICE AND REPAIR AND WAS FOUND TO HAVE A DAMAGED COMPONENT. SERVICE AND REPAIR WAS UNABLE TO REPAIR PRODUCT. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. IF ANY OTHER INFORMATION IS RECEIVED THIS WILL BE REPORTED VIA A SUPPLEMENT.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THIS REPORT IS PART OF THE SERVICE AND REPAIR DOCUMENTATION REMEDIATION. DEVICES THAT WERE RECEIVED BY SERVICE AND REPAIR HAVE EITHER BEEN REPAIRED AND RETURNED TO THE CUSTOMER OR DISCARDED BY SYNTHES, MAKING FURTHER PRODUCT EVALUATION BY MANUFACTURING OR ENGINEERING IMPOSSIBLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT ISSUES.

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES KNOBS BIND AND WONT RATCHET, BINDING. IT WAS REPORTED THAT DEVICE MALFUNCTIONED WHICH BEING USED ON A PATIENT. THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123378 VERTEBRAL BODY RETAINER MISC ORTHO SURGICAL INSTR LXH SYNTHES GMBH 5800305

    Patients

    Seq Age Sex Outcome Treatment
    1