BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M"STANDARD" 13X15 H4.5

    MDR report key: 18817321 · Received March 1, 2024

    Report

    Report Number
    3004788213-2024-00015
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    February 4, 2024
    Report Date
    August 14, 2024
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    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

    E1 PHONE NUMBER: (B)(6). 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" IS ERRONEOUS AND NO LONGER APPLIES. THE DEVICE WAS EVALUATED. DEVICE EVALUATION: THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE. ONLY THE SUPERIOR PLATE, POLYETHYLENE INSERT AND INFERIOR PLATE WERE RETURNED. A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED WITHOUT THE CARTRIDGE AND POST. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR SURGICAL FACTORS. 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 MEDICAL¿S CONTROL. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORT 3004788213-2024-00014.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO MOBI-C DEVICES DISASSEMBLED IN THE DISC SPACE INTRA-OPERATIVELY. THERE WAS NO HARM TO THE PATIENT OR DELAY TO THE PROCEDURE AND THE SURGERY WAS COMPLETED WITH AN ROI-C IMPLANTATION. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO MOBI-C DEVICES DISASSEMBLED IN THE DISC SPACE INTRA-OPERATIVELY. THERE WAS NO HARM TO THE PATIENT OR DELAY TO THE PROCEDURE AND THE SURGERY WAS COMPLETED WITH AN ROI-C IMPLANTATION. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932572 MOBI-C IMPLANT M"STANDARD" 13X15 H4.5 MOBI-C CERVICAL DISC PROTHESIS MJO LDR MEDICAL NA L083366

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose