BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C P&F IMPLANT 13X15 H4.5

    MDR report key: 11869810 · Received May 24, 2021

    Report

    Report Number
    3004788213-2021-00052
    Event Type
    Injury
    Date Received
    May 24, 2021
    Date of Event
    April 26, 2021
    Report Date
    August 19, 2021
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: PRODUCT WAS NOT RETURNED AND PHOTOS WERE NOT PROVIDED. A DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TRAUMA, PATIENT FACTORS OR OTHER UNKNOWN OPERATIONAL FACTORS. DHR REVIEW PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. 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 DEVICE AND SWITCH TO FUSION BECAUSE THE PATIENT CONTINUED TO HAVE AXIAL PAIN.

    Additional Manufacturer Narrative · 1

    PMA/510(K): SIMILAR TO 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 · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A MOBI-C DEVICE AND SWITCH TO FUSION BECAUSE THE PATIENT CONTINUED TO HAVE AXIAL PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768760 MOBI-C P&F IMPLANT 13X15 H4.5 MOBI-C IMPLANT M"STANDARD" 15X17 H5 MJO LDR MÉDICAL N/A L082401

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R