BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECICE SCREWS

    MDR report key: 12331862 · Received August 17, 2021

    Report

    Report Number
    3006179046-2021-00448
    Event Type
    Malfunction
    Date Received
    August 17, 2021
    Date of Event
    July 9, 2021
    Report Date
    October 8, 2021
    Manufacturer
    NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
    Product Code
    HSB
    UDI-DI
    00887517952745
    PMA / PMN Number
    K193617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED SECTION: G3, H2, H3 H6. THE REPORTED ISSUE OF SCREW BREAKAGE WAS NOT CONFIRMED, HOWEVER AFTER REMOVAL AND VISUAL INSPECTION, DISCOLORATION ON THE SCREW WAS CONFIRMED THROUGH IMAGES PROVIDED BY THE SURGEON. THE IQC INSPECTION DATA FOR THE LOT OF SS 3.5 LOCKING SCREW (LOT# 8061863) WAS REVIEWED AND CONFIRMED INDICATED PART; SS 5.0 LOCKING SCREW; MET DESIGN SPECIFICATIONS PER THE ENGINEERING DRAWINGS. THE CERTIFICATE FOR CONFORMANCE ALSO REVEALED THAT THE SCREW MET ALL MATERIAL SPECIFICATIONS. HENCE, THE BREAKAGE WAS NOT DETERMINED TO HAVE BEEN RELATED TO THE MANUFACTURING PROCESSES OR MATERIAL FAILURE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE ROOT CAUSE IS UNABLE TO BE DETERMINED AT THIS TIME. IF ANY ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE REMOVED LOCKING SCREW SHOWED SIGNS OF CORROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229599 PRECICE SCREWS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB NUVASIVE SPECIALIZED ORTHOPEDICS, INC. STP5-350 UNKNOWN 00887517952745

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR