BEUDAMED
    FDA Adverse Event Other Summary report: N

    STABILIZATION SCREW 3MM DIAMETER X 28MM LENGTH

    MDR report key: 2536327 · Received April 10, 2012

    Report

    Report Number
    9615741-2012-00018
    Event Type
    Other
    Date Received
    April 10, 2012
    Date of Event
    March 21, 2012
    Report Date
    April 10, 2012
    Manufacturer
    NEWDEAL SAS
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT DURING THE SAME SURGICAL PROCEDURE THE SCREW WAS IMPLANTED AND EXPLANTED BY THE DOCTOR AS HE SELECTED THE WRONG SIZE. HE BACKED IT OUT AND CHOSE ANOTHER SIZE THAT WAS IMPLANTED. IT WAS A DOCTOR ERROR. THERE WAS NO REPORT OF HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIZATION SCREW 3MM DIAMETER X 28MM LENGTH QUIX HWC NEWDEAL SAS EHS0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention