BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFEX, SURETAC II W/SPIKES, STERILE

    MDR report key: 283509 · Received June 23, 2000

    Report

    Report Number
    1219602-2000-00048
    Event Type
    Malfunction
    Date Received
    June 23, 2000
    Date of Event
    April 23, 2000
    Manufacturer
    SMITH & NEPHEW, INC., ENDOSCOPY DIV.
    Product Code
    MAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HOSP CONTRACT REPORTED THAT THE HEAD OF AN IMPLANT WAS BROKEN FREE IN THE JOINT APPROX. 7 WEEKS POST-OP. A PROCEDURE WAS PERFORMED TO REMOVE THE FRAGMENT AND REPAIR THE SITE. NO PT INJURY WAS REPORTED AS A RESULT OF THIS SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFEX, SURETAC II W/SPIKES, STERILE BIOABSORBABLE IMPLANT MAI SMITH & NEPHEW, INC., ENDOSCOPY DIV. NA 413472

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN