BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOBI-C IMPLANT, UNKNOWN SIZE

    MDR report key: 8707005 · Received June 18, 2019

    Report

    Report Number
    3004788213-2019-00179
    Event Type
    Injury
    Date Received
    June 18, 2019
    Report Date
    May 15, 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

    CORRECTION: A1, B1, B2, B5, B6, B7, D1, D2 (COMMON DEVICE NAME), E1, E2, E3, G3, G5 (PMA/510K), H3, H6 (PATIENT CODE AND DEVICE CODE). ADDITIONAL INFORMATION: D4 (UDI NUMBER), D10, H6 (RESULTS AND CONCLUSION CODES). 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 THE PATIENT EXPERIENCED HETERTOPIC OSSIFICATION POST-OPERATIVELY. NO INFORMATION REGARDING IF A REVISION SURGERY WAS PERFORMED OR ANY FURTHER INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS SUBMITTED TO SEND THE INITIAL REPORT. 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, RESPONDENT CHOSE : PRE-IMPLANTATION DIAGNOSIS WAS HNP (HERNIATION OF THE NUCLEUS PULPOSUS). DEVICE IMPLANTED AND OSSIFICATION OBSERVED AT C5/6. 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. PRODUCT NOT RETURNED.

    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 HNP (HERNIATION OF THE NUCLEUS PULPOSUS). DEVICE IMPLANTED AND OSSIFICATION OBSERVED AT C5/6. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED. INVESTIGATION ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503540 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 45 YR Other