BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 5649711 · Received May 12, 2016

    Report

    Report Number
    1030489-2016-01373
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 18, 2016
    Report Date
    June 20, 2016
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE-H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS :"VISUAL AND OPTICAL EXAMINATION IDENTIFIED WITNESS MARK ON THE EXTERNAL HEX, CONSISTENT WITH FINAL TIGHTENING. OPTICAL EXAMINATION OF THE INTERNAL HEX OF THE SET SCREW DID NOT IDENTIFY WITNESS MARKS CONSISTENT WITH SECONDARY TORQUE. TL HEX DRIVER USED DURING TIGHTENING NOT RETURNED FOR ANALYSIS. UNABLE TO DETERMINE ROOT CAUSE OF TIP SHEAR OF THE BOSS¿S FROM THE AVAILABLE INFORMATION."

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8115545, 510K # K030840 WAS 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PRE-OPERATIVE DIAGNOSIS FOR THIS PROCEDURE: LUMBAR ISTHMIC SPONDYLOLISTHESIS, PROCEDURE: "PLIF", LEVELS: L5-S1 IT WAS REPORTED THAT, INTRA-OP, WHEN THE SURGEON TRIED TO BREAK OFF THE SECOND SET SCREW AFTER BREAKING OFF THE FIRST SET SCREW, THE SECOND SET SCREW WAS BROKEN OFF AT THREAD PART SO CROSS LINK COULD NOT BE FIXED WITH A ROD. THE SURGEON TRIED TO REMOVE THE FIRST SET SCREW USING 3.0MM HEX REMOVABLE DRIVER FOR REPLACING NEW CROSS LINK BUT THE SCREW HOLE HAD BEEN STRIPPED FROM THE BEGINNING SO THE OLD CROSS LINK COULD NOT BE REMOVED. SO THE ENTIRE ROD WAS REMOVED AND THE SURGEON REPLACED IT WITH NEW ROD AND NEW CROSS LINK. NO PATIENT COMPLICATIONS WERE REPORTED DUE TO THE EVENT. WHEN FINAL TIGHTENING OF THE SECOND SET SCREW OF THE CROSSLINK THE SCREW THREAD DAMAGED AND TIP FELL INTO THE SURGICAL FIELD. PROVISIONAL TIGHTENING OF THE CROSSLINK AND FINAL TIGHTENING OF THE FIRST SET SCREW HAD BEEN ALREADY PERFORMED. IT WAS REPORTED THAT WHEN FINAL TIGHTENING, IT SOUNDED LIKE THE SCREW WAS ROUNDED OFF. THEY ATTEMPTED TO REMOVE THE FIRST SET SCREW BUT IT FAILED BECAUSE THE SCREW WAS ROUNDED OFF SO THEY REMOVED IT WITH THE ROD. NO FRACTURE WAS REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305326 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0405962W

    Patients

    Seq Age Sex Outcome Treatment
    1