BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEAD RING POST

    MDR report key: 4607903 · Received March 11, 2015

    Report

    Report Number
    1222895-2015-00014
    Event Type
    Malfunction
    Date Received
    March 11, 2015
    Report Date
    January 27, 2015
    Manufacturer
    INTEGRA BURLINGTON, MA, INC.
    Product Code
    HAW
    PMA / PMN Number
    K944463
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION ON 06/08/2015. RESULTS: DEVICE HISTORY RECORD REVIEWED FOR LOT #0308297 MANUFACTURED ON MAY 6, 2014 SHOW NO ANOMALIES RELATED TO THE REPORTED FAILURE. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR'S, VARIANCES OR REWORK. TWO YEAR LOOKBACK IN COMPLAINT MANAGEMENT SYSTEM FOR REPORTED FAILURE AND OR RELATED TO "EDGING WAS SHARP AND NOTCHES IN SOME" FOR THIS PRODUCT ID SHOWS THAT 3 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. ALL THREE COMPLAINTS WERE RECEIVED ON THE SAME DATE BY THE SAME CUSTOMER. NO NEW DESIGN OR MFG TRENDS HAVE BEEN IDENTIFIED. COMPLAINT NOT CONFIRMED, THERE WERE NO RAISED EDGES OR SHARP EDGES ON RETURNED PRODUCT. CONCLUSION: NO ROOT CAUSE ANALYSIS COULD BE PERFORMED AS THE COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT OF THREE INVOLVING THE SAME PRODUCT. CROSS REFERENCE WITH MFR. REPORT NUMBER 1222895-2015-00012 (PR 124673) AND MFR. REPORT NUMBER 1222895-2015-00013 (B)(4). IT WAS REPORTED THAT A HRP- HEAD RING POST; HAS EDGING THAT WAS SHARP WITH NOTCHES. THERE WAS NO PT INVOLVEMENT WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167363 HEAD RING POST NA HAW INTEGRA BURLINGTON, MA, INC. 0308297

    Patients

    Seq Age Sex Outcome Treatment
    1