BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 4915168 · Received July 15, 2015

    Report

    Report Number
    3003875359-2015-10339
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 3, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT PROVIDED BY REPORTER. AS THE LOT NUMBER PROVIDED IS SEEMINGLY INVALID, THE SELECTED MANUFACTURING LOCATION IS THE CURRENT LOCATION THE DEVICE IS MANUFACTURED. A LOT NUMBER OF 855054 WAS PROVIDED, HOWEVER, THE PROVIDED LOT NUMBER IS INVALID. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ PART/LOT COMBINATION UNKNOWN AT SYNTHES (B)(4), NO DHR REVIEW POSSIBLE. 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

    PRODUCT INVESTIGATION SUMMARY: ONE T-PAL SPACER APPLICATOR INNER SHAFT (PART 03.812.003 / LOT 8155054) WAS RECEIVED WITH THE FOLLOWING COMPLAINT DESCRIPTION: ¿THE SURGEON WAS IMPLANTING THE TPAL SPACER ON JULY 3, 2015; WHEN TRYING TO DISENGAGE THE TPAL HANDLE FROM THE IMPLANT, THE SHAFT WOULD NOT EASILY DISENGAGE. THE SURGEON WAS EVENTUALLY ABLE TO DISENGAGE THE SHAFT FROM THE IMPLANT AND COMPLETE THE SURGERY. IT WAS REPORTED THAT THE SHAFT WAS SUSPECTED TO BE BENT.¿ UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE, IT CAN BE SEEN THAT THE PROXIMAL END OF THE T-PAL SPACER IS BENT APPROXIMATELY 1.5° TO 2°. THE COMPLAINT CONDITION IS CONFIRMED. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE T-PAL SPACER APPLICATOR INNER SHAFT BELONGS TO THE T-PAL SPACER SYSTEM; THESE SPACERS ARE FOR USE IN PATIENTS WITH DEGENERATIVE DISC DISEASE. THIS DEVICE IS COUPLED WITH AN APPLICATOR HANDLE AND AN APPLICATOR KNOB FOR IMPLANT INSERTION. THE RETURNED APPLICATOR SHAFT WAS BENT AS DESCRIBED IN THE COMPLAINT CONDITION. THE REMAINDER OF THE INSTRUMENT IS IN GOOD CONDITION WITH NO SIGNS OF MISUSE OR ABUSE. THE ASSOCIATED DRAWING WAS REVIEWED: THE DESIGNS, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE ADEQUATE FOR THEIR INTENDED USE. THERE IS NOT ENOUGH INFORMATION AS TO HOW THIS BENDING OCCURRED. THE BENDING COULD HAVE OCCURRED AS A RESULT OF AN EXTERNAL FORCE BEING PLACED ON THE INSTRUMENT CAUSING IT TO BEND IN THE DIRECTION IT DID. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER IS 8155054. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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 AS FOLLOWS: A SURGEON WAS IMPLANTING THE T-PAL SPACER ON (B)(6) 2015; WHEN TRYING TO DISENGAGE THE T-PAL HANDLE FROM THE IMPLANT, THE SHAFT WOULD NOT EASILY DISENGAGE. THE SURGEON WAS EVENTUALLY ABLE TO DISENGAGE THE SHAFT FROM THE IMPLANT AND COMPLETE THE SURGERY. IT WAS REPORTED THAT THE SHAFT WAS SUSPECTED TO BE BENT. THE SURGERY WAS DELAYED BY 5 MINUTES BUT COMPLETED SUCCESSFULLY. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460026 T-PAL SPACER APPLICATOR INNER SHAFT MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 8155054

    Patients

    Seq Age Sex Outcome Treatment
    1