BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODISC-C

    MDR report key: 2966790 · Received February 18, 2013

    Report

    Report Number
    2520274-2013-00771
    Event Type
    Injury
    Date Received
    February 18, 2013
    Date of Event
    December 1, 2010
    Report Date
    December 22, 2010
    Manufacturer
    SYNTHES (USA) BRANDYWINE
    Product Code
    MJO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE EXACT PART NUMBER COULD NOT BE IDENTIFIED DEVICE WAS USED FOR TREATMENT. WITHOUT LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(4).

    Additional Manufacturer Narrative · 1

    THE AS RECEIVED CONDITION IS N/A SINCE NO IMPLANT WAS RETURNED FOR EVALUATION. SINCE NO EXPLANATION FOR THE PRODISC-C REMOVAL AND SUBSEQUENT FUSION WAS GIVEN, A REVIEW OF THE FUNCTIONAL AND DESIGN REQUIREMENTS TRACEABILITY MATRIX (FDRM) OR IMPLANT RISK ANALYSIS (FMEA) CANNOT BE COMPLETED. NO CHANGES TO THESE DOCUMENTS ARE WARRANTED AT THIS TIME. WITHOUT ANY CAUSE OR HAZARD BEHIND THE PRODUCT COMPLAINT, NO COMPLAINT REVIEW, JOURNAL REVIEW, OR DESIGN EVALUATION IS POSSIBLE. NO CHANGE TO THE IMPLANT DESIGN, TECHNIQUE, OR DESIGN DOCUMENTATION IS WARRANTED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED ON 11/4/2013. ORIGINAL AWARENESS DATE WAS 12/22/2010.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD PRODISC-C DEVICE REMOVED AND WAS FUSED AT THAT LEVEL, C-5/C-6. PATIENT HAD SURGERY TO REMOVE THE PRODISC ON (B)(6) 2010. NO OTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED SEVERE SYMPTOMS¿INCAPACITATION, UNABLE TO PERFORM¿INTERFERED WITH DAILY ACTIVITIES AND WAS HOSPITALIZED WITH SURGERY. IT WAS REPORTED THAT THE EVENT WAS RESOLVED, BUT PATIENT IMPAIRMENT IS UNKNOWN. THE PRODISC IMPLANTED IS MODEL OMD-5.

    Description of Event or Problem · 1

    THIS IS ONE OF ONE REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70220 PRODISC-C MJO SYNTHES (USA) BRANDYWINE OMD-5

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention