BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 9731601 · Received February 20, 2020

    Report

    Report Number
    1030489-2020-00182
    Event Type
    Injury
    Date Received
    February 20, 2020
    Report Date
    February 20, 2020
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    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 HAVE BEEN USED IN THE SURGERY: PART#: G9010001435, LOT#: H5273302, 510K#: K153589, UDI#: (B)(4); QTY# 1. PART#: G9010001441, LOT#: H5289360, 510K#: K153589, UDI#: (B)(4), QTY#: 1. PART#: G9010001441, LOT#: H5299464, 510K#: K153589, UDI#: (B)(4), QTY#: 1. IT IS UNKNOWN WHICH OF THE ABOVE IMPLANTS WERE RESPONSIBLE FOR THE ADVERSE EVENTS. ALSO, IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT OR NOT. 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 THE PATIENT UNDERWENT PLF(POSTERIOR LUMBAR FUSION) AT L1/2, L4/5 DUE TO SPINAL CANAL STENOSIS. POST-OP, SYMPTOM OCCURRED AT L5/S. HENCE AN REVISION SURGERY PERFORMED ON (B)(6) 2019 IN WHICH THE FIXATION RANGE OF LOWER LEVEL EXTENDED. NO ANY OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT. EVERYTHING THAT HAD BEEN IN THE PATIENT WAS LEFT AS IT WAS. SCREW INSERTION WAS PERFORMED AT S, AND PLIF WAS PERFORMED AT L5/S. TWO RO12 DEGREE 12×22 WERE PLACED. LATERAL CONNECTOR WAS USED FOR THE SCREW AT S, AND MRC WAS PLACED NEAR L4/5. ROD PLACEMENT WAS PERFORMED ON THE MEDIAL SIDE AND CONNECTION WAS PERFORMED. NO OTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197759 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R