BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 7662078 · Received July 4, 2018

    Report

    Report Number
    1030489-2018-00951
    Event Type
    Malfunction
    Date Received
    July 4, 2018
    Report Date
    September 18, 2018
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 75446535, 510K # K042025, UDI# (B)(4). IS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    VISUAL FUNCTIONAL DEMINSONAL VISUAL REVIEW CONFIRMS SCREW BREAKAGE 4 THREADS DOWN FROM THE BASE OF THE BONE SCREW HEAD. VISUAL AND MICROSCOPIC EXAMINATION OF THE AREA OF FRACTURE INITIATION DID NOT IDENTIFY A PRE-EXISTING SURFACE DEFECT NEAR THE AREA OF CRACK ORIGINATION THAT COULD CONTRIBUTE TO CRACK PROPAGATION. MICROSCOPIC EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE WITH GENTLY CONVEX PROGRESSIVE STRIATIONS THROUGH THE CROSS-SECTIONAL AREA OF THE BONE SCREW, CONSISTENT WITH CYCLIC FATIGUE. THE MAJOR AND MINOR DIAMETER OF THE SCREW WERE CHECKED AND MEET PRINT SPEC. THE FAILURE APPEARS TO BE THE RESULT OF CYCLIC FATIGUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: STENOSIS ON THE LEFT SIDE OF L5 / S. SCREW BREAKAGE IS ON THE RIGHT SIDE OF S1. STENOSIS IS ASSOCIATED WITH BONE PROLIFERATION AT L5 / S1 PROCEDURE: FUSION WAS PERFORMED AT L5 / S1. TLIF WAS PERFORMED. CAGE WAS INSERTED FROM LEFT SIDE. IT WAS REPORTED THAT ON AN UNKNWON DATE, POST-OP, THE SCREW THREAD ON THE LEFT SIDE OF S1 AT L5 / S1 WAS BROKEN AND STENOSIS ON THE LEFT SIDE OF L5 / S REPORTED. PATIENT COMPLICATIONS WERE REPORTED AS UNKNOWN AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504532 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA W08C1012

    Patients

    Seq Age Sex Outcome Treatment
    1