BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-FLEX POLAR HEAD POSITIONER

    MDR report key: 2425170 · Received January 18, 2012

    Report

    Report Number
    1221538-2012-00001
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Report Date
    December 20, 2011
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Removal / Correction Number
    1221538-11/14/11-001(R)
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT. THE RETURNED HEAD POSITIONER PASSED DEVICE SPECIFICATION PARAMETERS BUT DID NOT MEET OVERLOAD TESTING SPECS. DISASSEMBLY OF THE RETURNED UNIT SHOWED THAT AN EXCESSIVE AMOUNT OF LUBRICANT HAD BEEN APPLIED TO AN INTERNAL PART. MIGRATION OF THE LUBRICANT HAD PREVENTED CURING THE THREADLOCKER ADHESIVE WHICH IS APPLIED TO AN ADJUSTMENT SETSCREW. THE FAILURE OF THE ADHESIVE TO HOLD THE SETSCREW OVER TIME INTRODUCES THE POTENTIAL FOR REDUCTION OF THE LOAD CAPACITY OF THE DEVICE. FURTHER INVESTIGATION SHOWED THAT THE METHOD OF APPLICATION OF THE THREADLOCKER ADHESIVE WAS ISOLATED TO AN INDIVIDUAL ASSEMBLY TECHNICIAN. FIELD ACTION 1221538-11/14/11-001(R) WAS INITIATED TO ADDRESS ALL POTENTIALLY IMPACTED UNITS. AS A CORRECTIVE ACTION, THE ASSEMBLY PROCESS HAD BEEN REVISED TO ELIMINATE INCONSISTENCIES IN LUBRICANT APPLICATION, AND TO SPECIFY SUFFICIENT CURING TIME OF THE ADHESIVE PRIOR TO FINAL ASSEMBLE. ASSEMBLY TECHNICIANS HAVE BEEN TRAINED TO THE NEW PROCESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011, ALLEN MEDICAL RECEIVED A HEAD POSITIONER DEVICE THAT REPORTEDLY FAILED OUT DISTRIBUTOR'S INCOMING INSPECTION. THE HEAD POSITIONER WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX POLAR HEAD POSITIONER SURGICAL HEAD POSITIONER FWZ ALLEN MEDICAL SYSTEMS A-70701-A2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1