BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19420628 · Received May 29, 2024

    Report

    Report Number
    3004788213-2024-00039
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Date of Event
    March 17, 2024
    Report Date
    October 28, 2024
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663018326
    PMA / PMN Number
    SEEH10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D9, G1, AND H3. ADDITIONAL INFORMATION IN D4: EXPIRATION DATE & UDI NUMBER, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED DEFORMATION DAMAGE TO THE POST AS WELL AS GOUGES TO THE PEEK CARTRIDGE. THE IMPLANT WAS ASSEMBLED WITH AN INSERTER (MB9001R-1 LOT 310232903/20) AND INSERTED THE IMPLANT INTO A CERVICAL SPINE MODEL. THE IMPLANT WAS ABLE TO RELEASE FROM THE CARTRIDGE AS EXPECTED INTO THE DISC SPACE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THE DEFORMATION DAMAGE / GOUGING COULD POSSIBLY BE ATTRIBUTED TO THE DEVICE BEING DAMAGED WHEN THE SURGEON WAS TRYING TO REMOVE THE PEEK. THE DIFFICULTY DETACHING THE PEEK COULD POSSIBLY BE ATTRIBUTED TO PATIENT ANATOMY OR INEXPERIENCE OF THE SURGEON. 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.

    Additional Manufacturer Narrative · 0

    POSTAL CODE: (B)(6). 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. 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 · 0

    IT WAS REPORTED THAT DURING AN INITIAL MOBI-C SURGERY, THE SURGEON WAS UNABLE TO DETACH THE PEEK CARTRIDGE DUE TO THE DISC SPACE OF THE PATIENT BEING TOO NARROW. THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE, WHICH WAS COMPLETED USING A SECOND MOBI-C WITH NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL MOBI-C SURGERY, THE SURGEON WAS UNABLE TO DETACH THE PEEK CARTRIDGE DUE TO THE DISC SPACE OF THE PATIENT BEING TOO NARROW. THERE WAS A 30 MINUTE DELAY TO THE PROCEDURE, WHICH WAS COMPLETED USING A SECOND MOBI-C WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1940690 MOBI-C IMPLANT M"STANDARD" 13X15 H4.5 MOBI-C CERVICAL DISC PROTHESIS MJO LDR MEDICAL NA L083574 03662663018326

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose