BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEBRAL BODY SPREADER- ANGLED

    MDR report key: 2971255 · Received February 21, 2013

    Report

    Report Number
    8030965-2013-00565
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE DEVICE IS OVER 7 YEARS OLD. THE SPINDLE FOR THE RATCHETING MECHANISM HAD BROKEN AWAY FROM IT'S HOLDER ON THE HANDLE. THE DISTRACTOR CORRESPONDS TO THE DRAWINGS AND PROCESSES AT THE TIME OF MANUFACTURE TOO MUCH FORCE WAS APPLIED TO THE HOLDER SECURING THE SPINDLE CAUSING THE LASER WELD TO BREAK. THE INSTRUMENT IS OVER 7 YEARS OLD AND WAS SECURED WITH ONE LASER WELD ACCORDING TO THE DRAWING AT THE TIME OF MANUFACTURE. THE SCREW HAS BEEN SECURED WITH 3 LASER WELDS SINCE (B)(6) 2008. DURING A DISC REPLACEMENT SURGERY, THIS DEVICE REMOBILIZES THE MOTION SEGMENT. THIS INSTRUMENT IS ALSO AVAILABLE FOR FUSION PROCEDURES. THE INSTRUMENT IS NO LONGER USABLE SINCE A THREADED PIN IS MISSING FROM THE LINKAGE IN THE LOCKING MECHANISM. THIS INSTRUMENT HAS A SINGLE LASER SPOT TO RETAIN EACH SCREW. THE DRAWING FOR THIS SPECIFIC INSTRUMENT REQUIRES THE SCREWS TO BE RETAINED WITH ONE LASER SPOT.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    DURING A L4-L5 ANTERIOR LUMBAR FUSION, THE VERTEBRAL BODY SPREADER BROKE. REPORTEDLY THE PIN CAME OUT OF ONE OF THE ENDS. THE PART WAS TOSSED ASIDE AND ANOTHER ONE WAS USED. A SECOND ISSUE THAT OCCURRED WAS WHEN THE SURGEON WAS INSERTING THE TRIAL INTO THE HOLDER FOR THE FRA, THE TIP OF THE HOLDER BENT WHEN HE TOOK IT OUT. SURGERY WAS NOT PROLONGED AND NO ADVERSE EFFECT TO THE PATIENT WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75950 VERTEBRAL BODY SPREADER- ANGLED VERTEBRAL BODY SPREADER HTD SYNTHES GMBH A7OA42

    Patients

    Seq Age Sex Outcome Treatment
    1