BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROMEO2

    MDR report key: 6295415 · Received February 2, 2017

    Report

    Report Number
    3007728266-2016-00001
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    October 12, 2016
    Report Date
    November 11, 2016
    Manufacturer
    SPINEART SA
    Product Code
    KWP
    PMA / PMN Number
    K081165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR. (B)(6) BROUGHT IN TWO PEDICLE SCREWS EXPLANTED FROM A PATIENT WHICH ARE BROKEN. THEY WERE USED IN L2 OF A PATIENT TREATED FOR AN L1 BURST FRACTURE (CONSTRUCT FROM T10 TO L2). PATIENT HAS SOLID FUSION T10 TO L1 AND WAS ASYMPTOMATIC; HOWEVER, HAD AN INFECTION IN HER BACK AND NEEDED SURGERY. ENTIRE CONSTRUCT WAS REMOVED. DR. (B)(6) NOTED THAT BOTH SCREWS APPEAR TO HAVE AN ELONGATED NECK WHICH APPEAR TO BE FROM MATERIAL CREEP OVER TIME. DEVICES WILL BE SENT FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81273 ROMEO2 POLYAXIAL SCREW DIAM.6 LG45 KWP SPINEART SA ELL-PS 06 45-S 2-1792

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization