BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLS TOP SET-SCREW T-HND Q-REL STD

    MDR report key: 1181632 · Received September 30, 2008

    Report

    Report Number
    1649384-2008-00510
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 30, 2008
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    HXX
    Removal / Correction Number
    1649384-03/20/08-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS AN INSTRUMENT AND IS NOT IMPLANTABLE. THE RESULTS OF THE REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PART MET SPECIFICATION. VISUAL INSPECTION OF THE PART FOUND THE INNER ROD UNLOCKED. FUNCTIONAL EVALUATION FOUND THE SPRING IN THE ASSEMBLY WAS MISALIGNED. THE ROOT CAUSE IS DETERMINED TO BE USER ERROR, INCORRECT ASSEMBLY AFTER CLEANING. RC# 1649384-03/20/08-001-C DOCUMENTS THE RELEASE AND DISTRIBUTION OF ASSEMBLY/DISASSEMBLY INSTRUCTIONS FOR THE PRODUCT.

    Description of Event or Problem · 1

    IN (B) (6) 2008, THE SALES REP REPORTED THAT DURING SURGERY THE INSTRUMENT WAS REPORTED TO BE WORN. IN (B) (4) 2008, AFTER EXAMINATION OF THE COMPLAINT RETURNED PART, THE CONCLUSION WAS MADE THAT THE PRODUCT WAS MISASSEMBLED RESULTING IN THE POTENTIAL FOR THE INSTRUMENT TO BE UNABLE TO RETAIN A CLOSURE TOP. THIS MALFUNCTION HAS RESULTED IN MEDICAL INTERVENTION IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLS TOP SET-SCREW T-HND Q-REL STD INCOMPASS HXX ABBOTT SPINE, INC. 31TT

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR