BEUDAMED
    FDA Adverse Event Death Summary report: N

    APPLIANCE, FIXATION, SPINAL INTERLAMINAL

    MDR report key: 9863781 · Received March 22, 2020

    Report

    Report Number
    1030489-2020-00350
    Event Type
    Death
    Date Received
    March 22, 2020
    Date of Event
    February 23, 2020
    Report Date
    March 22, 2020
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    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. SOME OF THE BELOW PRODUCTS ARE NOT APPROVED FOR SALE IN US. FOR SUCH PRODUCTS, THE SIMILAR PRODUCTS THAT ARE APPROVED FOR SALE IN US ARE MENTIONED IN THE BRACKETS: PRODUCT ID: G9010001540, LOT: H5581935, QTY.: (B)(4),(K): K153589, UDI: (B)(4). PRODUCT ID: 55740005525, LOT: H5553305, QTY.: (B)(4). (SIMILAR PRODUCT ID: 55840005525, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740005520, LOT: H5489003, QTY.: (B)(4). (SIMILAR PRODUCT ID: 55840005520, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740005520, LOT: H5264293, QTY.: (B)(4). (SIMILAR PRODUCT ID: 55840005520, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 8219500, LOT: VS18C001, QTY.: (B)(4), 510(K): K163181, UDI: (B)(4). PRODUCT ID: 8205300, LOT: CT18B033, QTY.: (B)(4), 510(K): K163181, UDI: (B)(4). PRODUCT ID: 8205300, LOT: CT17F014, QTY.: (B)(4), 510(K): K163181, UDI: (B)(4). PRODUCT ID: 7078396, LOT: H5569567, QTY.: (B)(4). (SIMILAR PRODUCT ID: 5540030, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 7078396, LOT: H5590071, QTY.: (B)(4). (SIMILAR PRODUCT ID: 5540030, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 7078396, LOT: H5590104, QTY.: (B)(4). (SIMILAR PRODUCT ID: 5540030, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740006535, LOT: H5530456, QTY.: (B)(4). (SIMILAR PRODUCT ID: 55840006535, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740006545, LOT: H5571645, QTY.: (B)(4). (SIMILAR PRODUCT ID: 55840006545, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 5531199, LOT: 0686003W, QTY.: (B)(4) (SIMILAR PRODUCT ID: 5541199, 510(K): K132471, UDI: (B)(4)). PRODUCT ID: 5531198, LOT: 0684985W, QTY.: (B)(4). (SIMILAR PRODUCT ID: 5541198, 510(K): K132471, UDI: (B)(4)). PRODUCT ID: G869H021, LOT: 0579956W, QTY.: (B)(4). (SIMILAR PRODUCT ID: 869-021, 510(K): K040962, UDI: (B)(4)). PRODUCT ID: 55740006545, LOT: H5566395, QTY.: (B)(4). (SIMILAR PRODUCT ID: 55840006545, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55740006535, LOT: H5530456, QTY.: (B)(4). (SIMILAR PRODUCT ID: 55840006535, 510(K): K113174, UDI: (B)(4)). 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

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PSEUDOARTHROSIS AFTER COMPRESSION FRACTURE AT T12 AND L1. SHE UNDERWENT THORACOLUMBAR VERTEBRAL POSTERIOR FUSION AT T10-L4. ISSUES SUCH AS INTRA-OPERATIVE MASSIVE BLEEDING WAS NOT FOUND DURING THE OPERATION IN WHICH THE REPORTED PRODUCTS WERE IMPLANTED AND THE OPERATION ITSELF HAD BEEN COMPLETED WITHOUT ANY PROBLEMS. ANTERIOR FIXATION WAS SCHEDULED TO BE PERFORMED ON (B)(6) 2020. HOWEVER, THE PATIENT¿S HEALTH CONDITION WORSENED ON (B)(6) 2020; AND ON (B)(6) 2020, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT KNOWN. POSTOPERATIVE NECROPSY WAS NOT PERFORMED ACCORDING TO THE WISHES OF THE PATIENT'S FAMILIES, AND IT BECAME IMPOSSIBLE TO DETERMINE THE CAUSE OF DEATH. ORIGINALLY, THE PATIENT HAD THROMBUS IN THE LOWER LIMBS AND HAD A POOR HEART FUNCTION, AND BECAUSE THE PATIENT¿S GENERAL CONDITION WAS NOT GOOD, THE SCHEDULED OPERATION HAS BEEN ONCE POSTPONED, AND THIS SURGERY WAS PERFORMED. IT WAS SAID THE OPERATION WAS PERFORMED AFTER THE PATIENT AND THE PATIENT¿S FAMILIES WERE TOLD THAT THE RISK LEVEL WAS HIGH. DOCTOR¿S ADDITIONAL COMMENTS: THE SURGEON CONSIDERED THAT IT WAS NOT A PROBLEM RELATED TO THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327536 APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death