BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 50MM

    MDR report key: 12433471 · Received September 7, 2021

    Report

    Report Number
    1526439-2021-01838
    Event Type
    Injury
    Date Received
    September 7, 2021
    Report Date
    August 9, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNI
    UDI-DI
    10705034067919
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE: OSH, MNL, KWP, KWQ, NKB. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 CASE IS BEING LOGGED TO CAPTURE THE REVISION ASSOCIATED WITH (B)(4) WHICH RECEIVED AS ADDITIONAL INFORMATION. IT WAS REPORTED THAT, THE REVISION OF POSTERIOR LUMBAR SPINAL FUSION WAS PERFORMED. THE REASON FOR REVISION WAS ADJACENT SEGMENT DEGENERATION/ADJACENT LEVEL DISEASE. THE EXPLANTED PRODUCTS WERE EXPEDIUM PEDICLE SCREWS AND CFX SCREWS, BUT THE LOT NUMBERS ARE NOT AVAILABLE. THE IMPLANTS WERE DISCARDED AND NOT AVAILABLE FOR COLLECTION. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 50MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328650 EXPEDIUM SPINE SYSTEM SI POLYAXIAL SCREW 5.5 X 7 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION MNI MEDOS INTERNATIONAL SàRL CH 179712750 10705034067919

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN SCREWS