BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7141675 · Received December 22, 2017

    Report

    Report Number
    1030489-2017-02553
    Event Type
    Injury
    Date Received
    December 22, 2017
    Report Date
    May 9, 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

    PRODUCT ANALYSIS: VISUAL REVIEW CONFIRMS ROD BREAKAGE. SIGNIFICANT FRACTURE SURFACE SMEARING NOTED. MICROSCOPIC EXAMINATION OF THE UNDAMAGED AREAS OF THE FRACTURE SURFACES IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE WITH GENTLY CONVEX PROGRESSIVE STRIATIONS THROUGH THE CROSS-SECTIONAL AREA OF THE ROD, WHICH ARE INDICATIVE OF CYCLIC FATIGUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. 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

    IMAGE REVIEW - IN ONE OF THE PHOTO RIVER LINES CAN BE SEEN CONSISTENT WITH CYCLIC FATIGUE. 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 WAS PRE-OPERATIVELY DIAGNOSED WITH KYPHOSIS AND UNDERWENT UNSPECIFIED SURGERY. POST-OP, THE ROD BREAKAGE WAS OBSERVED ON BOTH THE SIDES. A REVISION SURGERY WAS PERFORMED TO REPLACE THE RODS. NO FRAGMENTS REMAINING IN THE PATIENT. LOW BACK PAIN WAS OBSERVED AS THE RESULT OF THE EVENT. THERE WAS A DELAY OF MORE THAN 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921684 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0240777W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R