BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AEGIS ANTERIOR LUMBAR PLATE SYSTEM

    MDR report key: 9429052 · Received December 6, 2019

    Report

    Report Number
    1526439-2019-52593
    Event Type
    Injury
    Date Received
    December 6, 2019
    Report Date
    November 12, 2019
    Manufacturer
    DEPUY SPINE INC
    Product Code
    HWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR AN UNKNOWN PLATES/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. OCCUPATION: J&J REPORTER. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. INVESTIGATION SUMMARY PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DDRA) FOR PATIENTS IMPLANTED WITH DEPUY SYNTHES AEGIS¿ ANTERIOR LUMBAR PLATE FOR ANTERIOR LUMBAR INTERBODY FUSION PROCEDURES. FAILED ANTERIOR LUMBAR INTERBODY FUSION HAS BEEN IDENTIFIED AS THE REPORTED COMPLICATION AS PER ICD 9 & 10 CATEGORIZATION EXPERIENCED BY THE FOLLOWING WITH CORRESPONDING INTERVENTION: 8 PATIENTS HAD A NEW SURGICAL REOPERATION PROCEDURE WITHIN 24 MONTHS FOLLOWING THE INDEX ANTERIOR LUMBAR INTERBODY FUSION FOR FUSION OR DEVICE REMOVAL WITHIN THE LUMBAR SPINE. 1 PATIENT HAD SUBSEQUENT SURGERY FOR A NEW SURGICAL PROCEDURE WITHIN 90 DAYS FOLLOWING THE INDEX ANTERIOR LUMBAR INTERBODY FUSION FOR NON-FUSION SURGERIES (EXCLUDING DEVICE REMOVAL) IN ANY REGION OF THE LUMBAR OR THORACIC SPINE. THIS IS FOR AEGIS ANTERIOR LUMBAR PLATE EU-MDR STUDY. THIS REPORT IS FOR ONE (1) UNKNOWN PLATE/AEGIS ANTERIOR LUMBAR PLATE SYSTEM. THIS REPORT IS 1 OF 9 FOR (B)(4). A COPY OF THE CLINICAL EVALUATION FORM IS BEING SUBMITTED WITH THIS REGULATORY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1226920 AEGIS ANTERIOR LUMBAR PLATE SYSTEM AWL, VARIABLE HWJ DEPUY SPINE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention