BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8154114 · Received December 12, 2018

    Report

    Report Number
    1030489-2018-01639
    Event Type
    Injury
    Date Received
    December 12, 2018
    Report Date
    December 11, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5541113, 510K #K132471 AND UDI # (B)(4) WAS CLEARED IN THE UNITED STATES. 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) 2018, 2-2 FUSION WAS PERFORMED DUE TO T12 PSEUDARTHROSIS, POST-OP, DUE TO T10 SCREW BACKED OUT, PASTE WAS INJECTED AFTER REMOVING THE T10 SCREW AND THE HOOKS WERE PLACED AT T6-8 AND CONNECTION WAS PERFORMED WITH CONNECTORS LENGTHWISE ON (B)(6) 2018. POST-OP, THE BONES (TRANSVERSE PROCESS) STUCK TOGETHER WITH THE HOOKS AND THESE WERE CUT OUT AND BACKED OUT. REVISION WAS SCHEDULED FOR REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994932 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0565812W

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention