BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 4194719 · Received October 22, 2014

    Report

    Report Number
    1030489-2014-04105
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    PMA / PMN Number
    K021461
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: NO MATERIAL SURFACE DEFECT NOTED IMMEDIATELY ADJACENT TO THE INITIAL CRACK PROPAGATION AREA THAT COULD CONTRIBUTE TO CRACK INITIATION AND PROPAGATION IDENTIFIED. EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A MULTIMODAL FRACTURE, WITH INITIAL REGION WITH EVIDENCE OF PROGRESSIVE CONVEX STRIATIONS (BEACH MARKS) APPROXIMATELY 40% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA, FOLLOWED BY ANOTHER REGION OF INCREASED MATERIAL DISRUPTION AND SHEAR LIPS, WHICH ARE CONSISTENT WITH OVERLOAD WHICH APPEARS TO HAVE RESULTED IN ULTIMATE FAILURE OF THE IMPLANT. DIMENSIONAL INSPECTION CONFIRMS MAJOR AND MINOR DIAMETER WITHIN SPECIFICATION. AFTER VISUAL, OPTICAL AND DIMENSIONAL INSPECTION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANTS; UNABLE TO DEFINITIVELY DETERMINE SPECIFIC ROOT CAUSE OF THE FOREGOING EVENT FROM THE AVAILABLE INFORMATION. FEATURE OR DIMENSION. MAJOR DIAMETER: 4.0 +0.0/-0.15; SPECIFICATION LOCATION: 3120510/0520 REV. B PG. 1 OF 2, LOC. B15 MEASUREMENT METHOD: MITUTOYO; 150MM CALIPER, MODEL# 500-769-10 ID# (B)(4). INSPECTOR/DATE: (B)(4) / 10 NOVEMBER 2014 MEASUREMENT RESULTS 3.89 PASS / FAIL: PASS.

    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. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: 7200040 / LOT: UNK ALTHOUGH IT IS UNKNOWN IF THIS DEVICE CONTRIBUTED TO THE REPORTED ADVERSE EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE A PATIENT UNDERWENT A CERVICAL FUSION PROCEDURE. SOMETIME POST-OP, THE SCREW WAS FOUND BROKEN ON THE RIGHT SIDE OF C7 CERVICAL PLATE CONSTRUCT. A REVISION SURGERY OF C5-C7, WITH C6 CORPECTOMY WAS PERFORMED APPROXIMATELY ONE YEAR 9 MONTHS POST-OP AND THE END OF THE SCREW WAS LEFT IN THE RIGHT SIDE OF C7. IT WAS ALSO REPORTED THAT THE FUSION FAILED AND AS A RESULT OF THIS EVENT, REVISION FUSION WAS PERFORMED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674166 ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK 3120513 H12D1282

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention 40MM PLATE