BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 4123149 · Received September 26, 2014

    Report

    Report Number
    3003875359-2014-10290
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE INVESTIGATION OF THE RETURNED INSTRUMENTS HAS SHOWN THAT THE KNOB OF THE INNER SHAFT IS INDEED COMPLETELY BROKEN OFF, THOUGH THE BROKEN PIECE WAS NOT RETURNED. WE PRESUME THAT THE DAMAGE OF THE APPLICATOR INNER SHAFT MAY HAVE BEEN CAUSED DUE TO HIGH MECHANICAL FORCE WHICH WAS APPLIED DURING USE. NOTE THAT THIS IS A RATHER DELICATE INSTRUMENT AND SHOULD BE USED AS PER TECHNIQUE GUIDE 036.001.088. THE APPLICATOR KNOB WAS NOT RETURNED FOR INVESTIGATION. THIS LOT WAS MANUFACTURED IN FEBRUARY 2013 AND MET ALL SPECIFICATIONS AND RELEASE CRITERIA AT THE TIME. NEVERTHELESS, AS WE HAVE HAD SIMILAR COMPLAINTS OF SUCH NATURE, OUR PDC HAS DECIDED TO REVISIT THIS PARTICULAR DESIGN IN ORDER TO ELIMINATE SUCH PROBLEMS IN THE FUTURE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON DECIDED TO USE T-PAL (TRANSFORAMINAL POSTERIOR ATRAUMATIC LUMBAR SYSTEM ) WITH VIPER 2 SYSTEM AS A MINIMALLY INVASIVE CASE. AFTER PREPARATION OF THE (TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION)TLIF SITE THE SURGEON TRIED TO INSERT THE T-PAL TRIAL BUT FOUND THAT THERE WAS SOMETHING OBSTRUCTING THE WAY. IT WAS NOTED THAT THE BALL TIP OF THE INSTRUMENT WAS BROKEN INSIDE THE APPLICATOR KNOB. THE SURGEON CHANGED THE DECISION FROM USING T-PAL MINIMALLY INVASIVE SURGERY (MIS) TO DEVEX CAGE, THERE WERE REPORTS OF A TWO HOUR TIME DELAY. THIS REPORT IS FOR 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602404 T-PAL SPACER APPLICATOR INNER SHAFT MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8132703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention