BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C P&FIMPLANT 15X19 H5

    MDR report key: 12589907 · Received October 7, 2021

    Report

    Report Number
    3004788213-2021-00136
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    September 14, 2021
    Report Date
    April 6, 2022
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D4: UDI NUMBER AND EXPIRATION DATE. ADDITIONAL INFORMATION IN H4 AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: REVISION CONFIRMED VIA PHOTOGRAPH. X-RAYS PROVIDE EVIDENCE OF THE OSTEOLYSIS AND METALLOSIS. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN PATIENT OR OPERATIONAL FACTORS. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET 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 ALTHOUGH A MOBI-C DEVICE APPEARED TO BE INTACT AND FUNCTIONING CORRECTLY, THE PATIENT WAS EXPERIENCING NECK AND ARM PAIN THE SURGEON THOUGHT WAS COMING FROM THAT LEVEL. ADDITIONALLY, THE DOCTOR SUSPECTS THERE IS METALLOSIS AND OSTEOLYSIS ADJACENT TO THE DEVICE ON A CT SCAN. SINCE OSTEOLYSIS AND METALLOSIS ARE KNOWN AFFECTS OF ORTHOPEDIC IMPLANTS, THE SURGEON DECIDED THE BEST TREATMENT WAS TO REMOVE THE MOBI-C DEVICE AND FUSE THE LEVEL.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT ALTHOUGH A MOBI-C DEVICE APPEARED TO BE INTACT AND FUNCTIONING CORRECTLY, THE PATIENT WAS EXPERIENCING NECK AND ARM PAIN THE SURGEON THOUGHT WAS COMING FROM THAT LEVEL. ADDITIONALLY, THE DOCTOR SUSPECTS THERE IS METALLOSIS AND OSTEOLYSIS ADJACENT TO THE DEVICE ON A CT SCAN. SINCE OSTEOLYSIS AND METALLOSIS ARE KNOWN AFFECTS OF ORTHOPEDIC IMPLANTS, THE SURGEON DECIDED THE BEST TREATMENT WAS TO REMOVE THE MOBI-C DEVICE AND FUSE THE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485267 MOBI-C P&FIMPLANT 15X19 H5 SIMILAR TO MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL NA L081298

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R