BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3932572 · Received July 14, 2014

    Report

    Report Number
    1030489-2014-03240
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    January 14, 2014
    Report Date
    July 29, 2016
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    K091974
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :VISUAL REVIEW CONFIRMS SCREW BREAKAGE NEAR THE BASE OF THE NECK, JUST BELOW THE BONE SCREW HEAD. THE BONE SCREW PORTION BELOW THE FRACTURE IS MISSING, AND NOT RETURNED FOR ANALYSIS. VISUAL AND OPTICAL 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. SIGNIFICANT FRACTURE SURFACE DAMAGE AND SMEARING IS NOTED. MICROSCOPIC EXAMINATION OF THE UNDAMAGED PORTION OF THE FRACTURE SURFACE IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE AND GENTLY CONVEX PROGRESSIVE STRIATIONS THROUGH THE CROSS-SECTIONAL AREA OF THE BONE SCREW, CONSISTENT WITH CYCLIC FATIGUE. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PLIF, AT AN UNKNOWN TIME POST-OP IT WAS REPORTED THAT THE RIGHT S1 SCREW WAS BROKEN. X-RAYS SHOWED THAT THE LEFT S1 SCREW WAS ALSO BROKEN. PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE BROKEN SCREWS. AT AN UNKNOWN TIME POST-OP FROM THE REVISION, IT WAS NOTED THAT THE SCREW IS BROKEN FOR THE 2ND TIME. IT IS UNKNOWN AT THIS TIME IF THE PATIENT WILL UNDERGO A SECOND REVISION TO REPLACE THE BROKEN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409259 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG NA H13E3116

    Patients

    Seq Age Sex Outcome Treatment
    1