BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TLIF-C EI 12MM 8DEG 32/12

    MDR report key: 10712257 · Received October 21, 2020

    Report

    Report Number
    3013730328-2020-00028
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    August 19, 2020
    Report Date
    August 19, 2020
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260557776605
    PMA / PMN Number
    K170503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. H10: ADDITIONAL NARRATIVE: H3, H4, H6: PART TEI81232, LOT E19CL0255: RELEASE TO WAREHOUSE DATE: MAY 13, 2020. SUPPLIER: EIT. NO NON-CONFORMANCE REPORTS (NCR'S) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: A PRODUCT INVESTIGATION WAS COMPLETED: THE SPACER HAD SOME DEBRIS ALONG ITS BODY. THIS WAS LIKELY DUE TO A POOR STERILIZATION CYCLE. FUNCTIONAL TESTING WAS PERFORMED WITH THE RETURNED ASSEMBLY. AFTER A MODERATE APPLICATION OF FORCE, THE INSERTER KNOB WAS ABLE TO BE ROTATED SUCH THAT THE SPACER DETACHED FROM THE INSERTER. ALL COMPONENTS FUNCTIONED AS INTENDED, THERE WERE FUNCTIONAL DEFECTS DETECTED. THE OVERALL COMPLAINT WAS NOT CONFIRMED AS NO FUNCTIONAL DEFECT WAS IDENTIFIED WITH THE RECEIVED DEVICE. THE DEVICE SUCCESSFULLY RELEASES/RETAINS AS INTENDED. AS MENTIONED DURING VISUAL INSPECTION, THE OBSERVED DEBRIS LIKELY REMAINED AFTER A POOR STERILIZATION CYCLE. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE INVESTIGATION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. H11: CORRECTED DATA: B4: (B)(6) 2020 D10. 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

    PRODUCT COMPLAINT#: (B)(4). COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON HAD TO ABANDON USING THE CAGE AND INSERTION INSTRUMENTS BECAUSE OF THEIR INABILITY TO MAINTAIN A STRAIGHT LINE. THE THREAD THAT CONNECTED THE SILVER HANDLE TO THE TIGHTENING DEVICE FOR THE CAGE WAS WORN AND WAS A WEAK POINT IN THE INSERTION DEVICE MECHANISM. THE RATCHETED OR TENSION ATTACHMENT FOR THE CAGE CAUSED A DANGEROUS MISALIGNMENT OF THE BANANA CAGE DURING INSERTION. ONCE THE CAGE HAD BEEN ATTACHED TO THE INSERTION DEVICE IN THE CORRECT FASHION THE SURGEON SHOULD HAVE BEEN ABLE TO INSERT IT IN A DIRECT LINE WITH THE INSTRUMENT. THE ATTACHMENT OF THE CAGE WAS NOT ABLE TO HOLD THE STRAIGHT ALIGNMENT ,AND UPON INSERTION THE CAGE FLEXED AND WENT INTO THE SPINAL CANAL. IT IS CRUCIAL ESPECIALLY FOR MIS THAT THE CAGE BE ABLE TO BE INSERTED IN THE EXACT LINE THAT THE SURGEON PLACED IT IN. ONCE IN THE CORRECT POSITION OF THE DISC SPACE IT CAN RELEASE THE TENSION, THE HANDLE CAN MOVE MEDIALLY AND CAN GET IN THE DESIRED POSITION. WEAR OF THE INSERTION DEVICE CREATED AN UNSAFE SITUATION FOR THE PATIENT. THERE WAS A SURGICAL DELAY OF SIXTY (60) MINUTES. ANOTHER CAGE AND INSERTER WERE USED TO COMPLETE THE PROCEDURE. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CONSEQUENCES TO THE PATIENT. THIS COMPLAINT INVOLVE ELEVEN (11) DEVICES. THIS REPORT INVOLVES ONE (1) TLIF-C EI 12MM 8DEG 32/12. CONCOMITANT DEVICES REPORTED: IMPLANT INSERTER SH CONNECTION (PART NUMBER TFT30101, LOT E19DI0971, QUANTITY 1), VIPER PRIME INSERTER SHAFT (PART NUMBER 286750031, LOT UNKNOWN, QUANTITY 1), VIPER PRIME INSERTER HANDLE (PART NUMBER 286750032, LOT MF4262402, QUANTITY 1), PRIME STYLET DEPTH ADJUSTOR (PART NUMBER 286750041, LOT MF4288302, QUANTITY 1), VIPER PRIME INSERT DRIVE TUBE (PART NUMBER 286750034, LOT UNKNOWN, QUANTITY 1), CAGE/SPACER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), HANDLES (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS 8 OF 10 FOR (B)(4). THIS (B)(4) CAPTURES THE 10 OUT OF 11 DEVICES REPORTED/RECEIVED WHILE (B)(4) CAPTURES THE OTHER 1 OUT OF 11 DEVICES REPORTED/RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177426 TLIF-C EI 12MM 8DEG 32/12 INTERVERTEBAL FUSION DEVICE  W/BONE GRAFT, LUMBAR      MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH TUI81232 E19CL0255 04260557776605

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANT INSERTER SH CONNECTION| PRIME STYLET DEPTH ADJUSTOR| TLIF-C EI 12MM 8DEG 32/12| UNKNOWN CAGE/SPACER| UNKNOWN HANDLES| UNKNOWN INSERTION INSTRUMENTS| UNKNOWN RODS| VIPER PRIME INSERT DRIVE TUBE| VIPER PRIME INSERTER CARRIER| VIPER PRIME INSERTER HANDLE| VIPER PRIME INSERTER SHAFT| IMPLANT INSERTER SH CONNECTION| PRIME STYLET DEPTH ADJUSTOR| TLIF-C EI 12MM 8DEG 32/12| UNKNOWN CAGE/SPACER| UNKNOWN HANDLES| UNKNOWN INSERTION INSTRUMENTS| UNKNOWN RODS| VIPER PRIME INSERT DRIVE TUBE| VIPER PRIME INSERTER CARRIER| VIPER PRIME INSERTER HANDLE| VIPER PRIME INSERTER SHAFT