BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3811281 · Received May 15, 2014

    Report

    Report Number
    1030489-2014-02518
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: AP AND LATERAL XRAYS ARE SHOWN SHOWING A COMPLEX CONSTRUCT FOR A T12 BURST FRACTURE WHICH INCLUDES PEDICLE SCREWS FROM T9 TO L4. SCREWS ARE ABSENT AT T12 AND L1. RESIDUAL KYPHOSIS IS NOTED AT T12 WITH CONTINUED RETROPULSION OF THE POSTERIOR ASPECT OF T12. IN ADDITION THERE IS CONSIDERABLE DDD AT L4/5 AND A BROKEN ROD BELOW THE T11 SCREW ON THE LEFT. SOME LOSS OF CORRECTION IS EVIDENT FROM THE ANGULATION AT THE POINT OF ROD FRACTURE.

    Additional Manufacturer Narrative · 1

    THE ROD WAS RETURNED BROKEN INTO THREE PIECES, WITH THE LONGEST PIECE IS CRACKED AND IT APPEARS ANOTHER FRACTURE WAS IMMINENT. NEITHER OF THE FRACTURES HAD A SURFACE DEFECT NOTED ADJACENT TO THE INITIAL CRACK PROPAGATION AREA THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION IDENTIFIED. ONE FRACTURE SURFACE WAS SMEARED AND DID NOT PROVIDE MUCH ADDITIONAL INFORMATION. EXAMINATION OF THE OTHER FRACTURE SURFACE IDENTIFIED A MULTIMODAL FRACTURE, WITH INITIAL REGION WITH EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS (BEACH MARKS) APPROXIMATELY ~30-60% RESPECTIVELY OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION, AND A SHEAR LIP, WHICH ARE CONSISTENT WITH OVERLOAD WHICH APPEARS TO HAVE RESULTED IN ULTIMATE FAILURE OF THE IMPLANT. DIMENSIONAL INSPECTION CONFIRMS ROD DIAMETER BOTH ABOVE AND BELOW THE FRACTURE WITHIN PRINT SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL SURGICAL PROCEDURE AT T9-L4. SOMETIME POST-OP IT WAS FOUND THAT THE ROD WAS BROKEN ON THE LEFT SIDE AT T11. THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE ROD. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291106 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS NA 0137232W

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention SCREWS