BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT INSERTER SH CONNECTION

    MDR report key: 9173108 · Received October 9, 2019

    Report

    Report Number
    3013730328-2019-00045
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    September 11, 2019
    Report Date
    September 18, 2019
    Manufacturer
    EIT EMERGING IMPLANT TECHNOLOGIES GMBH
    Product Code
    MAX
    UDI-DI
    04260557775592
    PMA / PMN Number
    K170503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UDI: (B)(4). 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. THE DEVICE WAS INVESTIGATED AT EIT EMERGING IMPLANT TECHNOLOGIES GMBH. IT WAS NOTED THAT THE TLIF IMPLANT INSERTER INNER PIN BROKE AT THE PRE-DEFINED BREAKING POINT DUE TO APPLICATION OF A TOO HIGH TIGHTENING TORQUE. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A DEFINITIVE ROOT CAUSE FOR THE INNER PIN BREAKING COULD NOT BE POSITIVELY DETERMINED. HOWEVER, THE RESULTS OF THE INVESTIGATION PROVIDED BY EIT SUGGESTS THAT THE TLIF IMPLANT INSERTER INNER PIN BROKE AT THE PRE-DEFINED BREAKING POINT DUE TO APPLICATION OF A TOO HIGH TIGHTENING TORQUE. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INITIAL REPORTER: EIT EMERGING IMPLANT TECHNOLOGIES (B)(4). (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. 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

    INNER PIN IS BROKEN. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966814 IMPLANT INSERTER SH CONNECTION INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX EIT EMERGING IMPLANT TECHNOLOGIES GMBH TFT30101 E18DI0158 04260557775592

    Patients

    Seq Age Sex Outcome Treatment
    1