BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9127938 · Received September 27, 2019

    Report

    Report Number
    1030489-2019-01077
    Event Type
    Injury
    Date Received
    September 27, 2019
    Report Date
    September 27, 2019
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    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

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY. THESE PRODUCTS ARE NOT APPROVED FOR SALE IN US. THE SIMILAR PRODUCTS FOR EACH OF THE BELOW PRODUCT, THAT ARE APPROVED FOR SALE IN US, ARE MENTIONED IN BRACKETS "()" ACROSS EACH PRODUCT: PRODUCT ID: 5531113, LOT: 0292500W (QTY: 2) - (SIMILAR PRODUCT ID: 5541113, 510(K): K132471, UDI: (B)(4)). PRODUCT ID: 55740007570, LOT: H5139767 (QTY: 1), LOT: H5156464 (QTY: 1) - (SIMILAR PRODUCT ID: 55840007570, 510(K): K113174, UDI: (B)(4)). PRODUCT ID: 55790016540, LOT: 0276868W (QTY: 1), LOT: 0276870W (QTY: 1), LOT: 0279506W (QTY:1), LOT: H13K3638 (QTY: 1) - (SIMILAR PRODUCT ID: 54840016540, 510(K): K091974, UDI: (B)(4)). PRODUCT ID: 55790016545, LOT: 0259849W (QTY: 1), LOT: 0276080W (QTY: 1), LOT: 0277260W (QTY:1), LOT: H5080297 (QTY: 2) - (SIMILAR PRODUCT ID: 54840016545, 510(K): K091974, UDI: (B)(4)). PRODUCT ID: 55790017540, LOT: H5152971 (QTY: 6) - (SIMILAR PRODUCT ID: 54840017540, 510(K): K091974, UDI: (B)(4)). PRODUCT ID: 55790017545, LOT: H5152567 (QTY: 2) - (SIMILAR PRODUCT ID: 54840017545, 510(K): K091974, UDI: (B)(4)). PRODUCT ID: 1556300500, LOT: 0298944W (QTY: 2) - (SIMILAR PRODUCT ID: 1556200500, 510(K): K131321, 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. 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 ON (B)(6) 2015, THE PATIENT UNDERWENT FIXATION AT T8-S2AI AND L1-L3 OBLIQUE LUMBAR INTERBODY FUSION IN A TWO-STAGE OPERATION FOR DEGENERATIVE SCOLIOSIS. ON AN UNKNOWN DATE, POST-OP, '(B)(6)' INFECTION WAS NOTED AROUND PATIENT'S T7 VERTEBRA. CT PERFORMED FOR THE PATIENT REVEALED T7 COMPRESSION FRACTURE AND IT SEEMS THAT KYPHOSIS PROCEEDED DUE TO THIS COMPRESSION FRACTURE. ORIGINALLY, THE BACK MUSCLE WAS FLIMSY AND THE IMPLANT HEAD WAS SLIGHTLY VISIBLE. IT SEEMED THAT THE HOOK ON THE MOST CRANIAL SIDE DID NOT CUT OUT, AND THE HEAD OF T7 CAME OUT DUE TO COMPRESSION FRACTURE. THE SURGEON REPORTED THAT '(B)(6)' INFECTION OCCURRED ABOUT 5 MM FROM THERE. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019, IN WHICH TWO HOOKS AND FOUR PEDICLE SCREWS AT T8-T10 WERE REMOVED DUE TO WOUND INFECTION. THE ROD WAS CUT IN THE OPERATIVE FIELD AND BENDING WAS PERFORMED USING AN IN-SITU BENDER ON THE MOST CRANIAL SIDE. AFTER REMOVING THE HOOKS AND SCREWS, WASHING OF 6000 ML WAS PERFORMED, VANCOMYCIN WAS SPRAYED, AND THEN WOUND CLOSURE WAS PERFORMED. THE EXPLANTED PRODUCTS WERE DISCARDED IN THE FACILITY DUE TO INFECTION REPORTED. NO COMPLICATIONS AFTER THE REVISION SURGERY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924177 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK USA, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other| R