BEUDAMED
    FDA Adverse Event Other Summary report: N

    C-FLEX POLAR HEAD POSITIONER

    MDR report key: 2253140 · Received August 31, 2011

    Report

    Report Number
    1221538-2011-00013
    Event Type
    Other
    Date Received
    August 31, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO INJURIES TO REPORT AND NO IMPACTS TO THE CASE. THE DISTRIBUTOR REPORTED TO THE ALLEN REP. THE C-FLEX HAS NOT YET BEEN RETURNED FOR EVALUATION. WHEN THE INVESTIGATION BY OUR ENGINEER IS COMPLETED A FOLLOW-UP FILE WILL BE COMPLETED AND SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN ALLEN REP IN (B)(6) WAS CONTACTED BY DISTRIBUTOR (B)(6) REQUESTING A REPAIR OF A C-FLEX FOLLOWING UNWANTED MOVEMENT DURING A SPINAL SURGERY. THERE WERE NO INJURIES TO REPORT AND NO IMPACT TO THE CASE OR OUTCOME, THE DISTRIBUTOR REPORTED. THE DISTRIBUTOR IS SHIPPING THE C-FLEX TO ALLEN FOR EVALUATION AND REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-FLEX POLAR HEAD POSITIONER HEAD POSITIONER FWZ ALLEN MEDICAL SYSTEMS A-70700-A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK