BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 7108429 · Received December 12, 2017

    Report

    Report Number
    8030965-2017-50532
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Date of Event
    November 13, 2017
    Report Date
    November 13, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MAX
    UDI-DI
    07611819414600
    PMA / PMN Number
    K151276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NUMBER: 03.812.003, SYNTHES LOT NUMBER: 8830007, RELEASE TO WAREHOUSE DATE: 13.MAY.2014, MANUFACTURING SITE: (B)(4): NO NON-CONFORMANCE REPORTS (NCRS) 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. A MANUFACTURING INVESTIGATION WAS PERFORMED. ONE (1) ARTICLE 03.812.003 WITH LOT 8830007 (T-PAL SPACER APPLICATOR INNER SHAFT) RECEIVED AND FORWARDED FOR MANUFACTURING INVESTIGATION TO PLANT (B)(4): SUMMARY OF MANUFACTURING INVESTIGATION: THE ONLY ERROR WHICH WAS FOUND DURING INVESTIGATION WAS THAT THE COMPONENT FORK TIP 60051595 HAS BEEN BENT OPEN. IT HAS BEEN DETERMINED THAT THE FAULTY MANIPULATION, AS DESCRIBED IN THE CUSTOMER ASSESSMENT, WAS THE REASON FOR THIS DEVIATION. NO BREAKAGE WAS FOUND AS DESCRIBED IN THE COMPLAINT. THE FUNCTION OF THE APPLICATOR INNER SHAFT WAS TESTED BY FUNCTIONAL GAGE 60056816 WHICH SIMULATES THE APPLICATOR KNOB 03.812.004 AND FUNCTIONAL GAGE 60056814 WHICH SIMULATES THE APPLICATOR OUTER SHAFT 03.812.001. THE APPLICATOR INNER SHAFT IS MADE OUT TWO COMPONENTS WHICH ARE WELDED TOGETHER. THOSE COMPONENTS ARE MADE FROM DIFFERENT RAW MATERIALS WHICH ARE HEAT THREATENED TWO A DIFFERENT HARDNESS. ON THE TWO COMPONENTS THE HARDNESS HAS BEEN TESTED AND BOTH RESULTS ARE WITHIN SPECIFICATION. AFTER ALL THE FUNCTIONAL AND HARDNESS TESTS, IT CAN BE DETERMINED THAT MISHANDLING WAS THE CAUSE OF ERROR WHICH HAS LED TO THIS COMPLAINT. NO PRODUCTION FAULT HAS BEEN FOUND DURING TESTING. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. 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

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. REPORTER CONTACT NUMBER WAS NOT PROVIDED. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    THIS REPORT IS FOR ONE (1) T-PAL SPACER APPLICATOR INNER SHAFT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2017, SURGERY FOR LUMBAR CANAL STENOSIS (LCS) WAS PERFORMED USING THE T-PAL SYSTEM. THE FIXED AREA WAS L4-L5. DURING THE SURGERY, THE SURGEON TRIED TO REMOVE THE APPLICATOR INNER SHAFT FROM THE IMPLANT BUT HE COULD NOT DO IT. AS HE FORCIBLY REMOVED IT USING ANOTHER INSTRUMENT, THE TIP OF APPLICATOR INNER SHAFT BROKE. NO BROKEN PARTS WERE LEFT IN THE BODY, AND THE SURGERY WAS COMPLETED WITH A 10-MINUTES DELAY. NO ADVERSE CONSEQUENCE TO THE PATIENT REPORTED. CONCOMITANT DEVICES REPORTED: IMPLANT (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ACIS IMPLANT LORDOTIC/STANDARD 8MM HEIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889810 T-PAL SPACER APPLICATOR INNER SHAFT INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH 8830007 07611819414600

    Patients

    Seq Age Sex Outcome Treatment
    1