BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    MDR report key: 9490392 · Received December 18, 2019

    Report

    Report Number
    1030489-2019-01440
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    November 14, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MSD DEGGENDORF MFG
    Product Code
    OVD
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY DATED (B)(6) 2019: PRODUCT ID: 7967210, LOT: UNKNOWN, 510(K): K091813, UDI: (B)(4). PRODUCT ID: 7975520, LOT: 0711932W, 510(K): K110063, UDI: (B)(4). PRODUCT ID: 4986840, LOT: H5453664, 510(K): K133205, UDI: (B)(4). PRODUCT ID: 4986040, LOT: H5469189, 510(K): K133205, UDI: (B)(4). PRODUCT ID: 4986040, LOT: H5466195, 510(K): K133205, UDI: (B)(4). PRODUCT ID: 4986040, LOT: H5430748, 510(K): K133205, UDI: (B)(4). ALTHOUGH IT IS UNKNOWN WHETHER THE ABOVE PRODUCTS (THAT WERE USED FOR ANTERIOR FIXATION) CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH ADJACENT SEGMENTAL DISEASE; AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION 25 AND OBLIQUE LUMBAR INTERBODY FUSION 51. THE PROCEDURE WAS FINISHED AS PLANNED AND THERE WERE NO COMPLICATIONS. ON (B)(6) 2019, FOR THE PURPOSE OF CLINICAL TRIALS, THE PATIENT UNDERWENT POSTERIOR FIXATION WITH XIA SERRATO, MANUFACTURED BY (B)(4) STRYKER. IT WAS SAID THAT DURING THIS OPERATION, MAJOR BLEEDING OCCURRED WHEN THORACIC SPINE OSTEOTOMY WAS BEING PERFORMED, AND BLOOD TRANSFUSION OF ABOUT 8 UNITS WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT'S LEFT LEG COULD NOT MOVE AT THIS POINT AFTER IMPLANTS FROM ANOTHER MANUFACTURER WERE USED FOR POSTERIOR FIXATION. ALSO, REPORTEDLY, ON (B)(6) 2019, AFTER THE OPERATION, THE DOCTOR REMOVED THE BLOOD TUMOR FROM THE POSTERIOR SIDE. THE CAUSAL RELATIONSHIP WITH THE REPORTED IMPLANTS THAT WERE USED FOR ANTERIOR FIXATION COULD NOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283734 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR OVD MSD DEGGENDORF MFG NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other