BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

    MDR report key: 9685738 · Received February 10, 2020

    Report

    Report Number
    1030489-2020-00159
    Event Type
    Injury
    Date Received
    February 10, 2020
    Report Date
    February 10, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    LXH
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: -PRODUCT ID: 8670015, UDI-ASKU, 510K: EXEMPT, QTY: 1 -PRODUCT ID: 8670001, UDI- (B)(4), 510K: EXEMPT, QTY: 1 -PRODUCT ID: 54850015540, UDI- (B)(4), 510K: K143375, QTY: 1 -PRODUCT ID: 6440530, UDI-ASKU, 510K: K143375, QTY: 1 -PRODUCT ID: 641000040, UDI- (B)(4), 510K: K143375, QTY: 1 -PRODUCT ID: X1204273, UDI- (B)(4), 510K: K121760, QTY: 1. ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    POST OP, PATIENT WAS GOING THROUGH ALLERGY TESTING WITH A POSSIBLE ALLERGY DUE TO THE HARDWARE USED FOR SPINAL FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151053 ORTHOPEDIC MANUAL SURGICAL INSTRUMENT ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other