BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY SPREADER- ANGLED

    MDR report key: 3021643 · Received March 26, 2013

    Report

    Report Number
    8030965-2013-01162
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    December 11, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THEY WERE UNABLE TO REPAIR PRODUCT. THERE IS NO FURTHER INFORMATION AVAILABLE ON THIS EVENT. THE DHR IS NOT AVAILABLE FOR REVIEW AS THE DEVICE AS OVER 8 YEARS OLD AND OUR ERP IS NOT THAT OLD. 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. UPON FURTHER REVIEW, IT WAS NOTICED THAT THIS COMPLAINT IS CONSIDERED NON-REPORTABLE.

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES THAT A VERTICAL BODY SPREADER WILL NOT HOLD. THIS MALFUNCTION OCCURED DURING SURGERY. SERVICE AND REPAIR WAS UNABLE TO REPAIR THIS ITEM. NO ADDITITION INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 1 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124404 VERTEBRAL BODY SPREADER- ANGLED FORCEPS HTD SYNTHES GMBH A7NA50

    Patients

    Seq Age Sex Outcome Treatment
    1