BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 18162430 · Received November 17, 2023

    Report

    Report Number
    3004788213-2023-00128
    Event Type
    Injury
    Date Received
    November 17, 2023
    Date of Event
    September 10, 2023
    Report Date
    March 4, 2024
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UDI NUMBER: (B)(4) OR (B)(4). H6 ADDITIONAL INVESTIGATION TYPE CODE: 4110. CORRECTED INFORMATION IN D9 AND H3. ADDITIONAL INFORMATION IN D4 UDI NUMBER AND EXPIRATION DATE, H4, AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: -THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED THE INSERT IS FRACTURED. POTENTIAL ROOT CAUSE: -A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO EXCESSIVE FORCES EXPERIENCED BY THE IMPLANT POST-OPERATIVELY OR OTHER PATIENT SPECIFIC 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 ZIMVIE¿S CONTROL. DEVICE USAGE: -THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    D1: MOBI-C IMPLANT M"STANDARD" 13X15 H5 OR MOBI-C IMPLANT M"STANDARD" 13X15 H4.5. G3: THIS DEVICE IS NOT CLEARED WITHIN THE US, BUT IT IS SIMILAR TO THOSE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A MOBI-C IMPLANT WHOSE MOBILE CORE FRACTURED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A MOBI-C IMPLANT WHOSE MOBILE CORE FRACTURED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722023 SEE H10 MOBI-C CERVICAL DISC PROTHESIS MJO LDR MEDICAL NA L081748 OR L081757

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention| H