BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRODISC-L INSERTER F/SIZE M

    MDR report key: 3132668 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02410
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THE ADDITIONAL EVALUATION INDICATED THAT THE COMPLAINT OF PRODISC L INSERTER HAD SHOWN THAT THE LOCKING BALL AND ITS PUSH SPRING HAD COME APART AND THEREFORE THE DISTRACTOR DID NOT LOCK IN PLACE ANYMORE. UNFORTUNATELY WE WERE NOT ABLE TO DETERMINE THE EXACT CAUSE WHICH HAD LEAD TO THIS OCCURRENCE. WE WERE NOT ABLE TO RELIABLY DETERMINE A REASON THEREFORE BUT WE SUPPOSE THAT A MECHANICAL OVERLOADING SITUATION LEAD TO THE DAMAGE. THE INSERTER WAS ANALYSED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. FURTHER INVESTIGATION HAD SHOWN THAT THIS INSTRUMENT WAS MANUFACTURED IN THE YEAR 2005. BASED ON THESE FINDINGS WE CONCLUDED THAT THE CAUSE OF FAILURE WAS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY (B)(6) 2013, A SMALL, METAL SPRING FEATHER WAS SEEN ON THE IMAGE INTENSIFIER PICTURE. IT WAS IN THE PATIENT IN FRONT OF THE SPINAL COLUMN. THE PART WAS RETRIEVED. IT WAS NOTED WHEN EXAMINING THE DEVICE THAT THE SMALL BALL IN THE HOLE WHERE THE DISTRACTOR ATTACHES WAS MISSING, AS WELL AS THE SPRING FEATHER BEHIND IT. THE SMALL SCREW WAS IN PLACE. THE BALL WAS NOT FOUND. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235462 PRODISC-L INSERTER F/SIZE M LXH SYNTHES GMBH A7OA14

    Patients

    Seq Age Sex Outcome Treatment
    1