BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M"STANDARD" 15X17 H7

    MDR report key: 12832269 · Received November 17, 2021

    Report

    Report Number
    3004788213-2021-00153
    Event Type
    Malfunction
    Date Received
    November 17, 2021
    Date of Event
    October 11, 2021
    Report Date
    May 4, 2022
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    UDI-DI
    03662663018609
    PMA / PMN Number
    SEE-H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D4: UDI NUMBER, D9, AND H3. ADDITIONAL INFORMATION IN D4: EXPIRATION DATE, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION THE DEVICE WAS EVALUATED AND IT WAS CONFIRMED THAT THE IMPLANT HAS DISASSEMBLED. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO OVER-TURNING OF THE KNOB DURING ATTACHMENT TO THE INSERTER OR DUE TO OFF-AXIS FORCES APPLIED DURING INSERTION. DHR REVIEW PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET 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

    PROCODE: SIMILAR TO MJO. PMA: SIMILAR TO P110009. THIS DEVICE IS NOT CLEARED WITHIN THE US. 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 A MOBI-C PEEK CARTRIDGE DISASSEMBLED FROM THE IMPLANT DURING INSERTION IN THE DISC SPACE. THE IMPLANT WAS REMOVED FROM THE PATIENT AND A NEW IMPLANT WAS USED TO COMPLETE THE CASE WITHOUT PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED A MOBI-C PEEK CARTRIDGE DISASSEMBLED FROM THE IMPLANT DURING INSERTION IN THE DISC SPACE. THE IMPLANT WAS REMOVED FROM THE PATIENT AND A NEW IMPLANT WAS USED TO COMPLETE THE CASE WITHOUT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1732121 MOBI-C IMPLANT M"STANDARD" 15X17 H7 SIMILAR TO MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L082814 03662663018609

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown