BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PAL SPACER APPLICATOR KNOB

    MDR report key: 5029266 · Received August 25, 2015

    Report

    Report Number
    3003875359-2015-10381
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    August 11, 2015
    Report Date
    August 12, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4)- MANUFACTURING DATE: SEPTEMBER 25, 2014NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE 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 MANUFACTURING / INVESTIGATION SUMMARY: RECEIVED 1 ARTICLE OF APPLICATOR KNOB FOR MANUFACTURING INVESTIGATION. THE INSTRUMENT HAS NO VISIBLE DAMAGE. A FUNCTION TEST WITH THE APPLICATOR KNOB 03.812.004 WAS PERFORMED TOGETHER WITH THE COUNTERPARTS OF THIS COMPLAINT; APPLICATOR INNER SHAFT 03.812.003 LOT 7915848 AND THE APPLICATOR OUTER SHAFT 03.812.001 LOT 9079159. ADDITIONALLY, ALL PARTS OF THE COMPLAINT WERE TESTED IN COMBINATION WITH OUR SPECIAL GAGES THE APPLICATOR OUTTER SHAFT 03.812.001 (SPECIAL GAGE 60056814) AND THE APPLICATOR KNOB 03.812.004 (SPECIAL GAGE 60056816). THE RESULT OF THE FUNCTIONAL TESTS SHOWED THAT THE INSTRUMENT IS WORKING ENTIRELY IN ACCORDANCE TO WORK/TEST INSTRUCTIONS AND DESIGN SPECIFICATIONS. THEREFORE IT CANNOT BE CONFIRMED THAT THE INSTRUMENT CANNOT BE REMOVED FROM THE IMPLANT AS MENTIONED IN THE COMPLAINT DESCRIPTION. IT IS ASSUMED THAT A MISHANDLING OF THE OPENING/RELEASE FEATURE WAS THE REASON FOR THE MALFUNCTION. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT APPLICABLE. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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.

    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 INSTRUMENT COULD NOT BE REMOVED FROM THE IMPLANT FOLLOWING THE APPLICATION OF THE CAGE DURING A SURGICAL PROCEDURE ON (B)(6) 2015. THE CAGE (WITH THE ATTACHED INSTRUMENT) WAS REMOVED FOR DISMANTLING. THE SAME CAGE WAS THEN APPLIED WITH THE PUSHER. A DURA INJURY WAS ADDRESSED VIA SUTURES. A SURGICAL PROLONGATION OF SIXTY (60) MINUTES WAS NOTED. THIS REPORT IS 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561813 T-PAL SPACER APPLICATOR KNOB MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 9082945

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention