BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAL SPACER HANDLE

    MDR report key: 3020841 · Received March 26, 2013

    Report

    Report Number
    1719045-2013-00721
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). THERE WERE NO COMPLAINT-RELATED ANOMALIES, MRRS, OR NCRS ASSOCIATED WITH THIS LOT.

    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. PRODUCT WAS RECEIVED AT SERVICE AND REPAIRED (B)(4) 2012. PRODUCT HAS BEEN IN USE SINCE 4/14/09. SERVICE AND REPAIR DETERMINED THAT PRODUCT WAS BROKEN. SERVICE AND REPAIR WAS UNABLE TO REPAIR PRODUCT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING AN ANTERIOR LUMBAR INTERBODY FUSION PROCEDURE ON LEVELS L5-S1, THERE WAS A STEEP TRAJECTORY THUS THE SURGEON LACKED GOOD EXPOSURE TO THE OPERATIVE SITE. HE COULD NOT GET A GOOD ANGLE SO THE HANDLE BROKE OFF THE TRIAL SPACER. IT WAS ALREADY SOMEWHAT WORN OUT PRIOR TO THE PROCEDURE. SURGERY WAS COMPLETED WITHOUT ANY ADVERSE EFFECTS ON THE PATIENT AND WITHOUT DELAY TO THE PROCEDURE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    SERVICE AND REPAIR REPORT STATES THAT THE SPINDLE BROKE ON A TRIAL SPACER AND THE ARM BROKE OFF DURING DISTRACTION. A VERTEBRAL BODY RETAINER WAS ALSO DAMAGED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123840 TRIAL SPACER HANDLE FORCEPS HTD SYNTHES MONUMENT 6117911

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR