BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOBI-C IMPLANT M "STANDARD" 13X15 H5

    MDR report key: 15221538 · Received August 12, 2022

    Report

    Report Number
    3004788213-2022-00063
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    April 5, 2022
    Report Date
    October 13, 2022
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    UDI-DI
    03662663018333
    PMA / PMN Number
    SEE-H10
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT CLEARED IN THE US, HOWEVER IT IS SIMILAR TO MB3355, WHICH IS CLEARED UNDER P110009. 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

    DEVICE EVALUATION: VISUAL INSPECTION REVEALED THAT THE DEVICE WAS RETURNED DISASSEMBLED FROM THE PEEK CARTRIDGE. THE DEVICE WAS ABLE TO BE REASSEMBLED WITHOUT ISSUE. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO THE PATIENT'S DISC OSTEOARTHRITIS HAMPERING THE OPENING OF THE PEEK. DHR REVIEW : PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE CONTROL. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C IMPLANT COULD NOT BE POSITIONED CORRECTLY INTRA-OPERATIVELY; THE PATIENT PRESENTED WITH LATERAL DISC OSTEOARTHRITIS HAMPERING THE OPENING OF THE LATERAL JAWS WHICH LED TO A 10 MINUTE DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF DIRECT PATIENT IMPACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C IMPLANT COULD NOT BE POSITIONED CORRECTLY INTRA-OPERATIVELY; THE PATIENT PRESENTED WITH LATERAL DISC OSTEOARTHRITIS HAMPERING THE OPENING OF THE LATERAL JAWS WHICH LED TO A 10 MINUTE DELAY TO THE PROCEDURE. THERE WERE NO REPORTS OF DIRECT PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817061 MOBI-C IMPLANT M "STANDARD" 13X15 H5 MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L082871 03662663018333

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Unknown