BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT, UNKNOWN SIZE

    MDR report key: 8706901 · Received June 18, 2019

    Report

    Report Number
    3004788213-2019-00180
    Event Type
    Injury
    Date Received
    June 18, 2019
    Report Date
    July 23, 2020
    Manufacturer
    LDR MÉDICAL
    Product Code
    MJO
    PMA / PMN Number
    P110009
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLANT WAS NOT RETURNED FOR EVALUATION, SO NO RESULTS ARE AVAILABLE AND NO CONCLUSIONS CAN BE DRAWN. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MOBI-C PATIENT WAS FOUND TO HAVE HETEROTOPIC OSSIFICATION POSTOPERATIVELY. THERE WERE NO ADDITIONAL PATIENT IMPACTS REPORTED AND THERE ARE NO PLANS TO REVISE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER AND REFERENCE NUMBER ARE UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. ORIGINAL SURGERY DATE IS ALSO UNKNOWN. ONLY INFORMATION PROVIDED IS: INFORMATION WAS GATHERED THROUGH THE 2019 ANNUAL MOBI-C ESS SURGEON SURVEY. IN RESPONSE TO A QUESTION ASKING IF ANY GIVEN INDICATORS OF POTENTIAL ADVERSE EVENTS HAD BEEN OBSERVED IN THE PAST YEAR, HE ANSWERED HETEROTOPIC OSSIFICATION. PRE-IMPLANTATION DIAGNOSIS WAS CERVICAL HNP (HERNIATION OF THE NUCLEUS PULPOSUS). DEVICE IMPLANTED AND OSSIFICATION OBSERVED AT C4/5, 5/6 (NOTED ON FOLLOW UP XRAY 2 YEARS POST OP). DEVICE SIZE: 5 MM MEDIUM. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. INVESTIGATION IS STILL IN PROGRESS. CONCLUSION IS NOT YET AVAILABLE.

    Description of Event or Problem · 1

    MOBI-C P&F US: HETEROTOPIC OSSIFICATION INFORMATION WAS GATHERED THROUGH THE 2019 ANNUAL MOBI-C ESS SURGEON SURVEY. IN RESPONSE TO A QUESTION ASKING IF ANY GIVEN INDICATORS OF POTENTIAL ADVERSE EVENTS HAD BEEN OBSERVED IN THE PAST YEAR, RESPONDENT CHOSE : HETEROTOPIC OSSIFICATION. PRE-IMPLANTATION DIAGNOSIS WAS CERVICAL HNP (HERNIATION OF THE NUCLEUS PULPOSUS). DEVICE IMPLANTED AND OSSIFICATION OBSERVED AT C4/5, 5/6 (NOTED ON FOLLOW UP XRAY 2 YEARS POST OP). DEVICE SIZE: 5 MM MEDIUM. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501431 MOBI-C IMPLANT, UNKNOWN SIZE MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) MJO LDR MÉDICAL N/A NO INFORMATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other