BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT M"STANDARD" 15X15 H5

    MDR report key: 22731719 · Received August 6, 2025

    Report

    Report Number
    3004788213-2025-00045
    Event Type
    Injury
    Date Received
    August 6, 2025
    Date of Event
    July 15, 2025
    Report Date
    October 29, 2025
    Manufacturer
    LDR MEDICAL
    Product Code
    MJO
    UDI-DI
    03662663018531
    PMA / PMN Number
    SEEH10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    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

    CORRECTIONS IN D9 AND H3. ADDITIONAL INFORMATION IN 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 SIGNS OF DAMAGE. A FUNCTIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE CARTRIDGE AND POST NOT BEING RETURNED. THE PROVIDED X-RAYS SHOW THAT THE INFERIOR PLATE AND PEEK CORE HAVE MIGRATED ANTERIORLY OUT OF THE DISC SPACE. ADDITIONALLY, THE MIGRATED PLATE APPEARS TO BE ROTATED AND MISALIGNED. ROOT CAUSE: THIS EVENT COULD BE ATTRIBUTED TO UNKNOWN PATIENT OR SURGICAL FACTORS. THE RISK OF THIS EVENT IS DOCUMENTED IN THE RMR, AND IN THE IFU: THE MOBI-C INSTRUCTIONS FOR USE (IFU MB 1 US G 01.2023) WERE REVIEWED AND CITED BELOW. RISKS ASSOCIATED WITH A CERVICAL ARTIFICIAL DISC DEVICE, INCLUDING THE MOBI-C® CERVICAL DISC PROSTHESIS, INCLUDE: EARLY OR LATE LOOSENING OF THE COMPONENTS; DISASSEMBLY; BENDING OR BREAKAGE OF ANY OR ALL OF THE COMPONENTS; IMPLANT MIGRATION; IMPLANT MALPOSITIONING; IMPLANT SUBSIDENCE; LOSS OF FIXATION; SIZING ISSUES WITH COMPONENTS; ANATOMICAL OR TECHNICAL DIFFICULTIES; BONE FRACTURE; POSSIBLE TISSUE REACTION; METALLOSIS, AND/OR SCARRING; BONE RESORPTION; BONE FORMATION (INCLUDING HETEROTOPIC OSSIFICATION) THAT MAY REDUCE SPINAL MOTION OR RESULT IN A FUSION, EITHER AT THE TREATED LEVEL OR AT ADJACENT LEVELS; DEVELOPMENT OF NEW RADICULOPATHY, MYELOPATHY, OR PAIN; TISSUE OR NERVE DAMAGE CAUSED BY IMPROPER POSITIONING OR PLACEMENT OF IMPLANTS OR INSTRUMENTS; BENDING OR BREAKAGE OF A SURGICAL INSTRUMENT; LOSS OF NEUROLOGICAL FUNCTION; DECREASED STRENGTH OF EXTREMITIES; DECREASED REFLEXES; CORD OR NERVE ROOT INJURY; INTERFERENCE WITH RADIOGRAPHIC IMAGING BECAUSE OF THE PRESENCE OF THE IMPLANT; AND THE NEED FOR SUBSEQUENT SURGICAL INTERVENTION. 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 A PATIENT UNDERWENT A REVISION SURGERY TO CORRECT MOBI-C MIGRATION. THE INITIAL SURGERY APPEARED TO BE SUCCESSFUL, BUT 2-3 WEEKS LATER THE PATIENT DEVELOPED A SORE THROAT AND APHONIA. THESE SYMPTOMS IMPROVED BUT AN X-RAY WAS SCHEDULED, WHICH THEN SHOWED THAT THE INFERIOR PLATE AND INSERT HAD MIGRATED OUT OF THE DISC SPACE ANTERIORLY. THE REVISION SURGERY WAS SUCCESSFULLY PERFORMED, REPLACING THE MOBI-C WITH A FUSION/CAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO CORRECT MOBI-C MIGRATION. THE INITIAL SURGERY APPEARED TO BE SUCCESSFUL, BUT 2-3 WEEKS LATER THE PATIENT DEVELOPED A SORE THROAT AND APHONIA. THESE SYMPTOMS IMPROVED BUT AN X-RAY WAS SCHEDULED, WHICH THEN SHOWED THAT THE INFERIOR PLATE AND INSERT HAD MIGRATED OUT OF THE DISC SPACE ANTERIORLY. THE REVISION SURGERY WAS SUCCESSFULLY PERFORMED, REPLACING THE MOBI-C WITH A FUSION/CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1725542 MOBI-C IMPLANT M"STANDARD" 15X15 H5 PROSTHESIS, INTERVERTEBRAL DISC MJO LDR MEDICAL NA L084099 03662663018531

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O| H