BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T-PAL SPACER APPLICATOR INNER SHAFT

    MDR report key: 8492247 · Received April 8, 2019

    Report

    Report Number
    8030965-2019-62569
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 14, 2019
    Report Date
    March 14, 2019
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. : A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: PART: 03.812.003 LOT: 8475051 MANUFACTURING SITE: HÄGENDORF RELEASE TO WAREHOUSE DATE: 06.SEPTEMBER 2013 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED., PART: 03.812.003 LOT: 9403839 MANUFACTURING SITE: HÄGENDORF RELEASE TO WAREHOUSE DATE: 19.MAY 2015 A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED FOR PART: 03.812.003, LOT: 8475051. VISUAL INSPECTION: THE RECEIVED APPLICATOR INNER SHAFT IS IN A USED CONDITION. THE CLAMPS AT THE FRONT SHOW SCRATCH AND WEAR SIGNS. THE REST OF THE INSTRUMENT OTHERWISE IS IN GOOD CONDITION. FUNCTIONAL TEST: A FUNCTIONAL TEST TOGETHER WITH PRODUCT DEVELOPMENT (SUSTAINING ENGINEERING) WAS PERFORMED. ANOTHER APPLICATOR OUTER SHAFT, KNOB AND CAGE WERE AVAILABLE TO REPRODUCE THE COMPLAINED ISSUE. THE RETURNED INSTRUMENTS PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE CAGE COULD BE ATTACHED AND DETACHED WITH THE APPLICATOR INNER SHAFT AS INTENDED. NO DEFECT COULD BE DETECTED. USED PARTS FOR FUNCTIONAL CHECK: T-PAL OUTER SHAFT / PART NO. 03.812.001 / LOT. NO. 8662485 & 3313127 T-PAL KNOB / PART NO. 03.812.004 / LOT. NO. 9082945 & 3716401 CAGE / PART NO. 08.812.017 / LOT. NO. 3765095 DIMENSIONAL INSPECTION: AS THIS INVESTIGATION IS FOCUSED ON THE FUNCTIONAL ISSUE AND THIS WAS COVERED THROUGH THE FUNCTIONAL TEST PERFORMED. THEREFORE, NO MEASUREMENTS OF THE FEATURES ARE REQUIRED. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. SUMMARY: UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. BASED ON OUR INVESTIGATIONS, WE ONLY CAN ASSUME THAT POSSIBLY AN INSUFFICIENT CONNECTION, OR NOT EXACTLY FOLLOWING THE SURGICAL TECHNIQUE, COULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. PLEASE REFER TO THE CURRENT TECHNIQUE GUIDE. SINCE THE REPORTED OCCURRENCE COULD NOT BE REPLICATED, WE DETERMINE THIS COMPLAINT AS UNCONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. H3, H6: A PRODUCT INVESTIGATION WAS CONDUCTED FOR PART: 03.812.003, LOT: 9403839: VISUAL INSPECTION: THE RECEIVED APPLICATOR INNER SHAFT IS IN A USED CONDITION. THE CLAMPS AT THE FRONT SHOW SCRATCH AND WEAR SIGNS. THE REST OF THE INSTRUMENT OTHERWISE IS IN GOOD CONDITION. FUNCTIONAL TEST: A FUNCTIONAL TEST TOGETHER WITH PRODUCT DEVELOPMENT (SUSTAINING ENGINEERING) WAS PERFORMED. ANOTHER APPLICATOR OUTER SHAFT, KNOB AND CAGE WERE AVAILABLE TO REPRODUCE THE COMPLAINED ISSUE. THE RETURNED INSTRUMENTS PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE CAGE COULD BE ATTACHED AND DETACHED WITH THE APPLICATOR INNER SHAFT AS INTENDED. NO DEFECT COULD BE DETECTED. USED PARTS FOR FUNCTIONAL CHECK: T-PAL OUTER SHAFT / PART NO. 03.812.001 / LOT. NO. 8662485 & 3313127 T-PAL KNOB / PART NO. 03.812.004 / LOT. NO. 9082945 & 3716401 CAGE / PART NO. 08.812.017 / LOT. NO. 3765095 DIMENSIONAL INSPECTION: AS THIS INVESTIGATION IS FOCUSED ON THE FUNCTIONAL ISSUE AND THIS WAS COVERED THROUGH THE FUNCTIONAL TEST PERFORMED. THEREFORE, NO MEASUREMENTS OF THE FEATURES ARE REQUIRED. DRAWING/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. FAILURE IN MATERIAL OR PRODUCTION COULD NOT BE DETECTED. SUMMARY: UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. BASED ON OUR INVESTIGATIONS, WE ONLY CAN ASSUME THAT POSSIBLY AN INSUFFICIENT CONNECTION, OR NOT EXACTLY FOLLOWING THE SURGICAL TECHNIQUE, COULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. PLEASE REFER TO THE CURRENT TECHNIQUE GUIDE. SINCE THE REPORTED OCCURRENCE COULD NOT BE REPLICATED, WE DETERMINE THIS COMPLAINT AS UNCONFIRMED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    LOT NUMBER IS REPORTED TO BE EITHER 9403839 OR 8475051. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) SURGERY WAS PERFORMED FOR LUMBAR DISC HERNIA OF L5-L6. DURING THE SURGERY, AFTER THE SURGEON IMPLANTED A T-PAL 8MM IMPLANT, AN APPLICATOR INNER SHAFT COULD NOT BE DETACHED FROM THE IMPLANT WHEN THE SURGEON TRIED TO REMOVE THE SHAFT. THE SURGEON ATTACHED AN APPLICATOR OUTER SHAFT TO AN INNER SHAFT TO REMOVE IT BUT STILL COULD NOT REMOVE THE INNER SHAFT. THE SURGEON USED AN UNKNOWN PLIER AND AN UNKNOWN HAMMER TO COMPLETE THE SURGERY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ABOUT TEN (10) MINUTES SURGICAL DELAY. THERE WAS NO REPORTED ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT MEDICAL PRODUCTS: T-PAL APPLICATOR OUTER SHAFT (PART: 03.812.001, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A T-PAL SPACER APPLICATOR INNER SHAFT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285655 T-PAL SPACER APPLICATOR INNER SHAFT INTERVERTEBRAL FUSION DEVICE W/BONE GRAFT, LUMBAR MAX OBERDORF SYNTHES PRODUKTIONS GMBH 07611819414600

    Patients

    Seq Age Sex Outcome Treatment
    1