BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 6975546 · Received October 25, 2017

    Report

    Report Number
    1030489-2017-02244
    Event Type
    Injury
    Date Received
    October 25, 2017
    Report Date
    October 25, 2017
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. PRODUCT, LOT, QTY, SIMILAR DEVICE, UDI, 510(K) #. G9010001574, 0532806W, 2 , (B)(4) K031967; G869H021, UNK, 1, (B)(4), K040962; G8115530, 0437574W, 1 , (B)(4), K030840; G9010001575, 0501032W, 2 , (B)(4), K031967; G9010001575, 0510576W, 2 , (B)(4), K031967; G9010001599, 0364047W, 1; G9010001599, 0489118W, 5; G9010001606, 0503417W, 6. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, POST-OP, AN INFECTION WAS ALLEGED AFTER L3/5 POSTERIOR LUMBAR INTERBODY FUSION SURGERY. SURGERY FOR RECOVERY WAS PERFORMED ON (B)(6) 2017 TO TREAT THE INFECTION. AS THE WOUND WAS VERY SMALL, AFTER WASHING, THE IMPLANTS WERE LEFT AND INCISION WAS CLOSED. NO PATIENT COMPLICATIONS WERE REPORTED POST REVISION SURGERY. NO DEVICE MALFUNCTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756225 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R