BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYRENEES® CERVICAL PLATE SYSTEM

    MDR report key: 8224477 · Received January 7, 2019

    Report

    Report Number
    3004774118-2019-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2019
    Date of Event
    December 13, 2018
    Report Date
    September 18, 2019
    Manufacturer
    STRYKER-SPINE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE NON-TAPERED TORQUE DRIVER WAS RETURNED, VISUALLY AND MICROSCOPICALLY INSPECTED. UPON REVIEW OF THE PART, IT WAS OBSERVED THAT THE DISTAL TIP HAD SHEARED AT THE HEXALOBE FEATURE IN A CLOCKWISE DEFORMITY PATTERN. THE FRACTURE FACE WAS SMOOTH AND UNIFORM, SUGGESTIVE OF SUDDEN BRITTLE FRACTURE. THE FAILURE LIKELY OCCURRED IN TORSION.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A NON-TAPERED TORQUE DRIVER BROKE DURING FINAL TIGHTENING.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION YET. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A NON-TAPERED DRIVER BROKE DURING FINAL TIGHTENING. THE TIP OF THE DRIVER REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15533 PYRENEES® CERVICAL PLATE SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER-SPINE ADER

    Patients

    Seq Age Sex Outcome Treatment
    1 CATALOG: 201-90070, LOT: BUWD-016