BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 X 15M STANDARD SELF-DRILLING SCREW

    MDR report key: 4585019 · Received March 6, 2015

    Report

    Report Number
    3005739886-2015-00026
    Event Type
    Injury
    Date Received
    March 6, 2015
    Date of Event
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    PRECISION SPINE, INC
    Product Code
    OVE
    PMA / PMN Number
    K132029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED AS A SERIOUS INJURY DUE TO MEDICAL INTERVENTION REQUIRED TO REMOVE AND REPLACE 2 SCREWS DUE TO THEM NOT FULLY SEATING IN THE IMPLANT. OTHER. DIMENSIONAL EVALUATION WAS PERFORMED. DIMENSIONAL EVALUATION FOUND ALL DIMENSIONS THAT WOULD AFFECT SEATING OF THE SCREW IN THE PLATE WERE MEASURED AND FOUND TO BE WITHIN DESIGN SPECIFICATION. ENGINEERING EVALUATION STATES THAT REVIEW OF THE QUALITY INSPECTION REPORT SHOWS THAT ALL DIMENSIONS ARE WITHIN TOLERANCE TO THE DRAWING AND MANUFACTURING RECORDS NOTE THAT THERE WERE NO DEVIATIONS OR ANOMALIES FOR THIS LOT OF SCREWS. A FUNCTIONAL CHECK WAS PERFORMED WITH AN IMPLANT (37-PA-4206). BOTH SCREWS FUNCTIONED AS INTENDED AND FIT WITHIN THE MATING HOLE IN THE PLATE. THE ISSUE DESCRIBED IN THE COMPLAINT COULD NOT BE RECREATED. REVIEW OF MANUFACTURING RECORDS FOUND A TOTAL OF (B)(4) OF THIS LOT WERE MANUFACTURED AND RELEASED FOR DISTRIBUTION ON (B)(4) 2015 WITH NO DEVIATION OR ANOMALIES. A TWO-YEAR COMPLAINT HISTORY REVIEW FOUND THIS TO BE THE ONLY REPORT OF THIS NATURE RECEIVED FOR ANY PART NUMBER OF 37-SD-XXXX FAMILY OF STANDARD SELF-DRILLING CERVICAL SCREWS. THIS REPORT IS #1 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 3005739886-2015-00026/27).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A 3-LEVEL CERVICAL PROCEDURE PERFORMED ON (B)(4) 2015, 2 OF THE 3.5X 15MM STANDARD SELF-DRILLING SCREWS (37-SD-3515) WOULD NOT SEAT IN THE PLATE. THE SCREWS HAD TO BE REMOVED AND REPLACED WITH RESCUE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158420 3.5 X 15M STANDARD SELF-DRILLING SCREW OVE PRECISION SPINE, INC 4406PS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention