BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M"STANDARD" 15X19 H5

    MDR report key: 14982910 · Received July 11, 2022

    Report

    Report Number
    3004788213-2022-00051
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    May 25, 2022
    Report Date
    July 11, 2022
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    UDI-DI
    03662663018630
    PMA / PMN Number
    SEE-H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT CLEARED WITHIN THE US. HOWEVER, IT IS SIMILAR TO MB3595, WHICH IS CLEARED UNDER P110009. DEVICE EVALUATION: PRODUCT WAS NOT RETURNED AND PHOTOS WERE NOT PROVIDED. DEVICE EVALUATION COULD NOT BE COMPLETED. ROOT CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO TURNING THE KNOB THE WRONG WAY, AS ALLEGED BY THE COMPLAINANT. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED WHEN THE SURGEON WAS DETACHING THE PEEK CARTRIDGE INTRA-OPERATIVELY. THE SURGEON TURNED THE INSERTER THE INCORRECT WAY (HE LOOSENED INSTEAD OF TIGHTENING TO RELEASE THE IMPLANT), CAUSING THE IMPLANT TO DISASSEMBLE SO IT WAS NO LONGER IMPLANTABLE. ANOTHER MOBI-C PROSTHESIS WAS USED TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015328 MOBI-C IMPLANT M"STANDARD" 15X19 H5 MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L083017 03662663018630

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown