BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M"STANDARD" 15X15 H4.5

    MDR report key: 14639382 · Received June 8, 2022

    Report

    Report Number
    3004788213-2022-00043
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 11, 2022
    Report Date
    September 23, 2022
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    UDI-DI
    03662663018524
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT CLEARED WITHIN THE US, BUT IS SIMILAR TO MB3576, WHICH IS CLEARED UNDER P110009. 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.

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D9 AND H3. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE DEVICE WAS RETURNED DISASSEMBLED FROM THE PEEK CARTRIDGE. THE DEVICE WAS ABLE TO BE REASSEMBLED WITHOUT ISSUE. THE ONLY VISIBLE DAMAGE WAS SCRATCHES TO THE HEX NUT. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO OVER TURNING THE KNOB ON THE HANDLE OR ADJUSTING THE IMPLANT DURING INSERTION. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE CONTROL. DEVICE USE: 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 PEEK CARTRIDGE WAS BEING DETACHED INTRA-OPERATIVELY, AFTER THE IMPLANT WAS PLACED IN ITS POSITION. THE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C DEVICE WITHOUT PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C IMPLANT DISASSEMBLED WHEN THE PEEK CARTRIDGE WAS BEING DETACHED INTRA-OPERATIVELY, AFTER THE IMPLANT WAS PLACED IN ITS POSITION. THE IMPLANT WAS REMOVED AND REPLACED WITH ANOTHER MOBI-C DEVICE WITHOUT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631990 MOBI-C IMPLANT M"STANDARD" 15X15 H4.5 MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L082876 03662663018524

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown