BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 8411486 · Received March 12, 2019

    Report

    Report Number
    1030489-2019-00267
    Event Type
    Injury
    Date Received
    March 12, 2019
    Report Date
    April 9, 2019
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    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 # 1476006150, 510K #K121680 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS:VERTEBRAL BODY COLLAPSE OCCURRED AT L1 PROCEDURE:POSTERIOR FIXATION LEVELS IMPLANTED: T11¿L4 IT WAS REPORTED THAT, POST-OP, THE ROD BROKE. THE SCREW AND ROD WERE REPLACED. THERE WAS NO DELAY IN PROCEDURE TIME AS A RESULT OF ALLEGED EVENT. ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF EVENT. NO OTHER INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SUFFERED WITH BACK PAIN AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204573 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0270497W

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention