BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT M"STANDARD" 13X17 H6

    MDR report key: 12044289 · Received June 22, 2021

    Report

    Report Number
    3004788213-2021-00061
    Event Type
    Injury
    Date Received
    June 22, 2021
    Date of Event
    May 25, 2021
    Report Date
    September 22, 2021
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    UDI-DI
    03662663018395
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVALUATION: THE DEVICE WAS NOT RETURNED AND NO PHOTOS OR X-RAYS/IMAGING WERE PROVIDED SO AN EVALUATION WAS UNABLE TO BE PERFORMED. DHR REVIEW AND APPLICABLE ACTIONS: THE DHRS FOR THE PLATES AND MOBILE CORE WERE REVIEWED. ALL DIMENSIONS INSPECTED WERE FOUND CONFORMING TO THE DRAWING SPECIFICATIONS. ALL MATERIAL WAS FOUND TO MEET THEIR APPLICABLE REGULATION SPECIFICATIONS, INCLUDING MECHANICAL AND STRENGTH REQUIREMENTS. THERE ARE NO INDICATIONS THAT THERE WERE ANY MANUFACTURING OR MATERIAL ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. IFU REVIEW: THE IFU WAS REVIEWED AND WAS FOUND TO CONTAIN WARNINGS AND OTHER INFORMATION RELATED TO PAIN, DEVICE MIGRATION, AND DEVICE BREAKAGE. POTENTIAL CAUSE: THE POTENTIAL CAUSE CANNOT BE IDENTIFIED SINCE THERE IS INSUFFICIENT INFORMATION AVAILABLE. 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 THE PATIENT EXPERIENCED PAIN SEVERAL MONTHS POST-OP AFTER HE RAISED HIS ARM. A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANT. X-RAYS CLEARLY SHOWED A ROTATION OF A PROSTHESIS TRAY WITH A DISLOCATED NUCLEUS. IT IS UNCLEAR WHEN THE INFERIOR PLATE WAS FOUND TO HAVE INTEGRATED WITH THE BONE, BUT THE SUPERIOR PLATE DID NOT AND THE MOBILE CORE WAS BROKEN. THIS OCCURRED AT LEVEL C6-7.

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE: SIMILAR TO MJO. PMA/510(K) NUMBER: 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 THE PATIENT EXPERIENCED PAIN SEVERAL MONTHS POST-OP AFTER HE RAISED HIS ARM. A REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANT. X-RAYS CLEARLY SHOWED A ROTATION OF A PROSTHESIS TRAY WITH A DISLOCATED NUCLEUS. IT IS UNCLEAR WHEN THE INFERIOR PLATE WAS FOUND TO HAVE INTEGRATED WITH THE BONE, BUT THE SUPERIOR PLATE DID NOT AND THE MOBILE CORE WAS BROKEN. THIS OCCURRED AT LEVEL C6-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939852 MOBI-C IMPLANT M"STANDARD" 13X17 H6 MOBI-C CERVICAL DISC PROSTHESIS MJO LDR MÉDICAL N/A L081740 03662663018395

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| O| R