BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 6344627 · Received February 21, 2017

    Report

    Report Number
    1030489-2017-00345
    Event Type
    Injury
    Date Received
    February 21, 2017
    Report Date
    April 11, 2017
    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 WAS CLEARED IN THE UNITED STATES. (B)(4). PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. X-RAY REVIEW: POST-OP X-RAYS FOR T3- S1 PROVIDED. THESE IMAGES SHOW THAT SAGGITAL BALANCE HAS NOT BEEN CORRECTED. BY REPORT THERE HAS NOT BEEN FUSION AT L5-S1 EITHER WE CAN NOT ASSESS THIS ON THESE PROVIDED X-RAYS. ROOT CAUSE: SURGICAL TECHNIQUE, FAILURE OF FUSION.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: VISUAL REVIEW CONFIRMS ROD BREAKAGE. SIGNIFICANT FRACTURE SURFACE SMEARING NOTED. OPTICAL AND 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. DIMENSIONAL INSPECTION ROD DIAMETER CONFIRMS CONFORMANCE TO PRINT SPECIFICATION. NO MATERIAL DAMAGE NOTED ON ADJACENT SURFACE TO CRACK PROPAGATION WHICH COULD CONTRIBUTE TO CRACK PROPAGATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE.

    Description of Event or Problem · 1

    LEVELS IMPLANTED: T3-S2AI REVISION PROCEDURE: POSTERIOR SPINAL FUSION AT (T3-EXTENSION) IT WAS REPORTED THAT A ROD BROKE POST-OPERATIVELY, DUE TO UNSUCCESSFUL BONE UNION AT L5/S. PATIENT COMPLAINED OF BACK PAIN. ROD WAS REPLACED DURING REVISION SURGERY. NO FRAGMENT OF THE BROKEN IMPLANT REMAINED IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127875 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0273545W

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R