BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20019104 · Received August 21, 2024

    Report

    Report Number
    3004788213-2024-00067
    Event Type
    Injury
    Date Received
    August 21, 2024
    Date of Event
    July 13, 2024
    Report Date
    November 25, 2024
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663018326
    PMA / PMN Number
    SEEH10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4: 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.

    Additional Manufacturer Narrative · 0

    H6: ADDITIONAL METHOD CODE: 4110. ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE RETURNED ITEM MATCHES INFORMATION LISTED IN THE COMPLAINT FILE. VISUAL INSPECTION REVEALED THAT THE INFERIOR PLATE (MB063K LOT: 5378405), SUPERIOR PLATE (MB062K LOT: 5378388) AND THE POLYETHYLENE INSERT SHOW NO SIGNS OF DAMAGE. X-RAYS WERE PROVIDED WHICH SHOW THAT THE ENTIRE IMPLANT HAS MIGRATED ANTERIORLY. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR SURGICAL FACTORS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE NEUROSURGERY OPERATING ROOM, THE MOBI-C PROSTHESIS WAS FOUND TO HAVE EXTERNALIZED POSTOPERATIVELY ON DAY 1, CAUSING SEGMENTAL INSTABILITY AND SPINAL CORD COMPRESSION. EXPLANTATION FOLLOWED BY IMPLANTATION OF ANOTHER CERVICAL CAGE BROUGHT CLINICAL IMPROVEMENT TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IN THE NEUROSURGERY OPERATING ROOM, THE MOBI-C PROSTHESIS WAS FOUND TO HAVE EXTERNALIZED POSTOPERATIVELY ON DAY 1, CAUSING SEGMENTAL INSTABILITY AND SPINAL CORD COMPRESSION. EXPLANTATION FOLLOWED BY IMPLANTATION OF ANOTHER CERVICAL CAGE BROUGHT CLINICAL IMPROVEMENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286285 MOBI-C IMPLANT M"STANDARD" 13X15 H4.5 MOBI-C CERVICAL DISC PROTHESIS MJO LDR MEDICAL NA L083497 03662663018326

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention| H