BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKYLINE VARIABLE S-D SCW, 14MM

    MDR report key: 2915681 · Received January 15, 2013

    Report

    Report Number
    1526439-2013-10857
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MNI
    PMA / PMN Number
    PK052552
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BROKEN SECTION OF THE SCREW REMAINS IN THE PATIENT AS THE SURGEON HAS DETERMINED THAT IT IS ENCAPSULATED IN BONE AND POSES NO PROBLEM TO THE PATIENT. THE PORTION THAT WAS REMOVED HAS BEEN RETAINED BY THE HOSPITAL. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. COMPLAINT DATA IS REVIEWED MONTHLY BY CROSS FUNCTIONAL GROUPS WITHIN THE COMPANY TO ENSURE A ROBUST REVIEW. COMPLAINT DATA REVIEW FOUND NO EMERGING TRENDS. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    REVISION SURGERY TO ADDRESS PATIENT'S ADJACENT LEVEL DEGENERATIVE CONDITION FOUND ONE OF THE IMPLANTED SCREWS WAS BROKEN. THE TOP PORTION OF THE SCREW WAS REMOVED. THE SURGEON DETERMINED THAT THE REMAINING PORTION WAS ENCAPSULATED IN BONE AND IN NO DANGER OF BACKING OUT AND THAT SECTION REMAINS IN THE PATIENT. REPORTS THAT SCREW BREAKAGE RESULTED IN THE IMPLANTED PLATE BEING LOOSE. CONCOMITANT DEVICES: SKYLINE PLATE, CATALOG# UNKNOWN, QTY = 1. ADDITIONAL SKYLINE SCREWS, 186850014, QTY = 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22229 SKYLINE VARIABLE S-D SCW, 14MM ORTHOSIS, SPINAL PEDICLE FIXATION MNI DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention