BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT MOBIC M ST 15X15 H5 US

    MDR report key: 9566571 · Received January 8, 2020

    Report

    Report Number
    3004788213-2020-00002
    Event Type
    Malfunction
    Date Received
    January 8, 2020
    Date of Event
    December 5, 2019
    Report Date
    August 21, 2020
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663000062
    PMA / PMN Number
    P110009
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN B4, D4: EXPIRATION DATE, D10: DEVICE AVAILABILITY, H6: METHODS, RESULTS, AND CONCLUSION CODES. THE IDENTITY OF THE DEVICE WAS INSPECTED. THE SUPERIOR PLATE HAD PN: MB066K, LN: 5333012. THE INFERIOR PLATE HAD PN: MB107K, LN: 5333859. THE DEVICE WAS EXAMINED. VISUAL INSPECTION REVEALED NO VISIBLE DAMAGE. THE IMPLANT CAME WITH THE ALL PARTS DISASSEMBLED FROM THE REST OF THE COMPONENTS. THE IMPLANT WAS ABLE TO BE DISASSEMBLED AND REASSEMBLED WITH EASE. THE IMPLANT WAS THEN TESTED WITH AN INSERTER {OUTER SHAFT (PN: MB9001R-1, LN: 510250205/16), LOCKING NUT (PN: MB9001R-3, LN: 110085201 / 08), AND INNER SHAFT (PN: MB9001R-2, LN: 41015703/008)}. THE IMPLANT WAS ABLE TO BE FULLY ENGAGED WITH AND PROPERLY DETACHED FROM THE INSERTER. THE ASSOCIATED INSERTER WAS DISASSEMBLED AND TESTED. THE SPECIFIED IDENTITY OF THE DEVICE WAS CONFIRMED AND THE DEVICE WAS EXAMINED. VISUAL INSPECTION REVEALED NO VISIBLE DAMAGE. THE OUTER SHAFT WAS TESTED WITH A LOCKING NUT (PN: MB9001R-3, LN: 110085201 / 08) AND INNER SHAFT (PN: MB9001R-2, LN: 41015703/008). ANOTHER MOBI-C (MB3555, INFERIOR PLATE MB107K, LN: 5268164 AND SUPERIOR PLATE MB0066K, LN: 5286210) WAS CONNECTED TO THE INSERTER ASSEMBLY AND DISASSEMBLED BY TURNING THE KNOB. EVERYTHING ASSEMBLED AND OPERATED AS EXPECTED. THE INNER SHAFT (MB9001R-2, LN: 710173402/07) AND LOCKING NUT (PN: 9001R-3, LN: 71086210/33) FROM THE ORIGINAL ASSEMBLY WERE TESTED WITH A DIFFERENT OUTER SHAFT (PN: MB9001R-1, LN: 510250205/16). EVERYTHING ASSEMBLED AND OPERATED AS EXPECTED. THE DEMO MOBI-C (MB3555, INFERIOR PLATE MB107K, LN: 5268164 AND SUPERIOR PLATE MB0066K, LN: 5286210) WAS CONNECTED TO THE INSERTER ASSEMBLY AND DISASSEMBLED BY TURNING THE KNOB. THE INSERTER DID NOT CONTRIBUTE TO THE EVENT. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED. THERE WERE NO NONCONFORMANCES OR TEMPORARY DEVIATIONS ASSOCIATED WITH THIS LOT. ALL CHARACTERISTICS INSPECTED UPON INITIAL RECEIPT WERE FOUND CONFORMING TO SPECIFICATIONS. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET¿S CONTROL. IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE SURGEON WAS PLACING THE IMPLANT, HE HIT THE KNOB WITH THE MALLET WHEN THE PEAK CARTRIDGE RELEASED FROM THE IMPLANT AND THE IMPLANT DISASSEMBLED IN THE DISC SPACE. THE IMPLANT WAS REMOVED AND AN ALTERNATE OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. THE REPORTED COMPLAINT WAS CONFIRMED. AS THIS FAILURE IS REGULARLY OCCURRING WITH KNOWN CAUSES AND IMPACTS, A SUMMARY INVESTIGATION WAS COMPLETED. THE RETENTION FEATURE FAILURES TYPICALLY ARE CAUSED BY THE INCORRECT ORIENTATION OF THE IMPLANT ASSEMBLY AND THE UNDER TIGHTENING OR OVERTIGHTENING OF THE INSERTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE SURGEON WAS PLACING THE IMPLANT, HE HIT THE KNOB WITH THE MALLET WHEN THE PEAK CARTRIDGE RELEASED FROM THE IMPLANT AND THE IMPLANT DISASSEMBLED IN THE DISC SPACE. THE IMPLANT WAS REMOVED AND AN ALTERNATE OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE THE SURGEON WAS PLACING THE IMPLANT, HE HIT THE KNOB WITH THE MALLET WHEN THE PEAK CARTRIDGE RELEASED FROM THE IMPLANT AND THE IMPLANT DISASSEMBLED IN THE DISC SPACE. THE IMPLANT WAS REMOVED AND AN ALTERNATE OF THE SAME SIZE WAS USED TO COMPLETE THE CASE. THERE WERE NO REPORTED PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29310 IMPLANT MOBIC M ST 15X15 H5 US MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MEDICAL NA 5337304 03662663000062

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR