BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7543885 · Received May 25, 2018

    Report

    Report Number
    1030489-2018-00743
    Event Type
    Injury
    Date Received
    May 25, 2018
    Report Date
    May 25, 2018
    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 # 1556000500, 510K # K111942, UPN (B)(4) WAS CLEARED IN THE UNITED STATES. H6: 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. DEVICES OF OTHER MANUFACTURERS WERE USED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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 POSTERIOR SPINAL FUSION (PSF) DUE TO SCOLIOSIS AT T6-L5. POST-OPERATIVELY, DUAL ROD BROKE AND AS A RESULT THE POSTERIOR FUSION WAS FAILED. PATIENT UNDERWENT REVISION SURGERY IN WHICH POSTERIOR ROD WAS REPLACED, TOPICAL SCOLIOSIS WAS PERFORMED NEAR L2 AND ANTERIOR OBLIQUE LUMBAR INTER-BODY FUSION AND SURGERY (OLIF) WAS PERFORMED AT 2 INTERVERTEBRAL DISCS. NO FRAGMENT OF THE IMPLANT REMAINED IN THE PATIENT. SURGEON'S COMMENT: IF THE OLIF HAD BEEN PERFORMED IN THE INITIAL SURGERY, THE RESULTS MIGHT HAVE CHANGED SINCE OLIF IS A USEFUL TECH NIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386418 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0268425W

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention