BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEX RECONSTRUCTION SYSTEM

    MDR report key: 3272113 · Received August 8, 2013

    Report

    Report Number
    1030489-2013-03287
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Report Date
    July 12, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FILMS SUPPLIED FOR REVIEW FOUND: INITIAL COMPLEX CONSTRUCT C1-7. PEDICLE SCREWS AT C6 AND C7 FRACTURED FORCING REVISION. LATERAL CONNECTORS WERE APPLIED AND PEDICLE SCREWS WERE PLACED IN T1-4.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: SCREW RETURNED BROKEN AT ABOUT THE FOURTH THREAD. OPTICAL EXAMINATION OF THE ADJACENT SURFACE IMMEDIATELY AROUND THE CRACK ORI GINATION AREA DID NOT IDENTIFY A SURFACE DEFECT WHICH COULD CONTRIBUTE TO CRACK PROPAGATION. MICROSCOPIC EXAMINATION OF FRACTURE SURFACES REVEAL A FAIRLY FLAT, QUASI-BRITTLE FRACTURE, WITH PROGRESSIVE STRIATIONS, WHICH ARE INDICATIVE OF CYCLIC FATIGUE, FOLLOWED BY ULTIMATE FAILURE OF THE IMPLANT. THE FRACTURE SURFACE MORPHOLOGY SUGGESTS THE PRIMARY MODE OF FRACTURE TO BE CYCLIC FATIGUE, WITH A LOCALIZED REGION OF ORIGIN, DIRECTION OF PROPAGATION AND SUBSEQUENT FINAL FRACTURE. KEY DIMENSIONAL SPECIFICATIONS OF THE SCREW (I.E. MAJOR DIAMETER AND SHANK (INITIAL MINOR) DIAMETER) WERE MEASURED AND FOUND TO MEET THE PART SPECIFICATION. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH CYCLIC FATIGUE.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6958824, 510K # K081297 WAS CLEARED IN THE UNITED STATES. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE AT C1-2. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO EXTEND THE CONSTRUCT TO C7. SOMETIME POST OP IT WAS FOUND THAT THE LEFT SIDED SCREWS AT C6 AND C7 WERE FRACTURED. ANOTHER REVISION SURGERY WAS PERFORMED TO EXTEND THE FIXATION DUE TO SEVERE KYPHOSIS AT C7-T1. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373078 VERTEX RECONSTRUCTION SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H10F2904

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention