BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PEEK ROD

    MDR report key: 5247700 · Received November 24, 2015

    Report

    Report Number
    1526439-2015-10976
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 30, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: UPDATED TO INCLUDE INVESTIGATION DATE, INCLUDED PRODUCT CODE AND LOT CODE. CORRECTED DATA: BECAUSE THE SAMPLE WAS RECEIVED. CORRECTED TO INCLUDE YES BECAUSE DEVICE WAS EVALUATED. PRODUCT CODE 1867-82-045, LOT NUMBER: 5100867 WAS EVALUATED BY QUALITY ENGINEERING. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. FRACTURE ANALYSIS AND VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SAMPLES. A ROOT CAUSE CANNOT BE DETERMINED FROM THE SAMPLE AND THE INFORMATION PROVIDED. THE RESULTS OF FRACTURE ANALYSIS HAVE DETERMINED THAT A PROBABLE ROOT CAUSE MAY BE OVER LOAD BENDING FAILURE DUE TO UNEXPECTEDLY HIGH FORCES PLACED ON THE ROD. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DR. (B)(6) REVISED A PATIENT WHO WAS TREATED (B)(6) 2013 IN THE UNIVERSITY HOSPITAL OF BASEL WITH 4 EXPEDIUM SCREWS AND 2 PEEK RODS. THE PATIENT HAD SEVERE PAIN AT THE TREATED SEGMENT. AFTER OPENING THE PATIENT, DR. KֈLER REALIZED THAT ONE OF THE PEEK RODS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778445 UNKNOWN PEEK ROD UNKNOWN PEEK ROD KWQ DEPUY SYNTHES SPINE 5100867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R