BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M"STANDARD" 15X17 H5

    MDR report key: 18209349 · Received November 27, 2023

    Report

    Report Number
    3004788213-2023-00136
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    November 5, 2023
    Report Date
    June 12, 2024
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663018586
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: THIS DEVICE IS NOT CLEARED FOR USE IN OR MARKETED WITHIN THE US, HOWEVER IT IS A SIMILAR PRODUCT TO THOSE CLEARED BY P110009 UNDER PRODUCT CODE MJO. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    H3: "DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN (02)" NO LONGER APPLIES BUT CANNOT BE DELETED. CORRECTIONS IN H3. ADDITIONAL INFORMATION IN D4: EXPIRATION DATE AND UDI NUMBER, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. INSPECTION: THE RETURNED ITEM MATCHES INFORMATION LISTED IN THE COMPLAINT FILE. VISUAL INSPECTION REVEALED THAT THE INFERIOR PLATE (MB075K LOT 5378307) AND THE POLYETHYLENE INSERT AND SUPERIOR PLATE (MB074K LOT 5378073) HAVE DISASSEMBLED FROM THE PEEK CARTRIDGE. THE PEEK CARTRIDGE AND POST WERE NOT RETURNED. THE ITEM COULD BE FULLY DISASSEMBLED AND REASSEMBLED USING (B)(4) AND WITH THE PEEK CARTRIDGE AND POST FROM (B)(4) WITH NO DIFFICULTY. DHR REVIEW: THE DHR WAS REVIEWED. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT HIGHRIDGE¿S CONTROL. POTENTIAL ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO OFF-AXIS FORCES APPLIED DURING USE. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED WHEN IT WAS PLACED IN THE DISC SPACE INTRA-OPERATIVELY. ANOTHER MOBI-C IMPLANT WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED WHEN IT WAS PLACED IN THE DISC SPACE INTRA-OPERATIVELY. ANOTHER MOBI-C IMPLANT WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498263 MOBI-C IMPLANT M"STANDARD" 15X17 H5 MOBI-C CERVICAL DISC PROTHESIS MJO LDR MEDICAL NA L083456 03662663018586

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose