BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PLATES

    MDR report key: 12468948 · Received September 14, 2021

    Report

    Report Number
    1526439-2021-02007
    Event Type
    Injury
    Date Received
    September 14, 2021
    Report Date
    August 17, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA) PATIENTS WHO UNDERWENT DEPUY SPINE AEGIS INSTRUMENTATION. THE FOLLOWING COMPLICATIONS HAVE BEEN IDENTIFIED AS PER THE (B)(6) SPINE REGISTRY REPORT: A MALE PATIENT HAD HYPOTENSION SECONDARY TO RETRACTOR POSITIONING ON (B)(6) 2020. PROCEDURE DATE WAS (B)(6) 2020. A MALE PATIENT HAD A RIGHT SENSORY SINGLE-ROOT PERIPHERAL NEUROLOGIC COMPLICATION ON (B)(6) 2020. IMPLANT DATE WAS (B)(6) 2020. A MALE PATIENT HAD L4-L5 PSEUDOARTHROSIS ON (B)(6) 2021. IMPLANT DATE WAS (B)(6) 2020. A MALE PATIENT HAD A DURAL TEAR COMPLICATION ON (B)(6) 2020 AND (B)(6) 2021. IMPLANT DATE WAS (B)(6) 2020. A MALE PATIENT HAD A DURAL TEAR COMPLICATION ON (B)(6) 2021. IMPLANT DATE WAS (B)(6) 2021. A FEMALE PATIENT HAD BLEEDING ON (B)(6), 2021. IMPLANT DATE WAS (B)(6) 2021. THIS IS FOR DEPUY SPINE AEGIS INSTRUMENTATION. THIS REPORT IS FOR ONE (1) UNKNOWN PLATE. THIS IS REPORT 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366804 UNKNOWN PLATES APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention