BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT M"STANDARD" 17X19 (H4.5, 5, OR 6)

    MDR report key: 21379016 · Received February 13, 2025

    Report

    Report Number
    3004788213-2025-00006
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    January 19, 2025
    Report Date
    May 19, 2025
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    PMA / PMN Number
    SEEH10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE LOT NUMBER OF A RETURNED SUBCOMPONENT, THE PRODUCT MAY HAVE ONE OF THE FOLLOWING IDENTITIES: PART: MB2794 LOT: L082474 UDI: (B)(4). H3: "DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN" IS ERRONEOUS AND NO LONGER APPLIES. THE DEVICE WAS EVALUATED. CORRECTIONS IN D1, D4: CATALOG & LOT NUMBERS, D9, AND H3. ADDITIONAL INFORMATION IN D4: UDI NUMBER, H4, AND H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED NO DAMAGE TO THE DEVICE. A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED DUE TO THE PEEK CARTRIDGE AND POST NOT BEING RETURNED AS WELL. AN IMAGE OF THE EXPLANTED DEVICE AND TISSUE WERE PROVIDED AND THE SURGEON MENTIONED SOME BLACK TISSUE WAS FORMED AROUND THE DEVICE AND HAD STUCK THE PLATES TOGETHER. MEDICAL IMAGES WERE NOT PROVIDED AND THE IMPLANT BINDING IN THE PATIENT COULD NOT BE CONFIRMED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO UNKNOWN SURGICAL OR PATIENT 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.

    Additional Manufacturer Narrative · 0

    D4: THE UDI NUMBER IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS ARE NOT AVAILABLE. 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. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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 ADDRESS A MOBI-C PROSTHESIS THAT WAS STUCK/NOT MOVING. THE PROSTHESIS WAS REMOVED AND REPLACED WITH A FUSION CAGE AND PLATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO ADDRESS A MOBI-C PROSTHESIS THAT WAS STUCK/NOT MOVING. THE PROSTHESIS WAS REMOVED AND REPLACED WITH A FUSION CAGE AND PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637414 MOBI-C IMPLANT M"STANDARD" 17X19 (H4.5, 5, OR 6) PROSTHESIS, INTERVERTEBRAL DISC MJO LDR MEDICAL NA SEEH10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R