BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ¿MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD¿

    MDR report key: 6674153 · Received June 28, 2017

    Report

    Report Number
    3004608878-2017-00204
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    June 7, 2017
    Report Date
    June 7, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 07/25/2017. DEVICE HISTORY RECORD REVIEWED FOR PRODUCT ID A3101 WORK ORDER # 130642 SERIAL # (B)(4) MANUFACTURED ON 04/24/15 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. NO SERVICE HISTORY IS ON FILE FOR THIS DEVICE. A TWO YEAR LOOK BACK FROM 06/23/2015 TO 06/23/2017 FOR THIS REPORTED FAILURE USING KEY WORDS "SLIPPING" FOR PRODUCT ID A3101 SHOWS THAT 5 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. REPORT OF SLIPPAGE WAS UNCONFIRMED WHEN THE UNIT WAS TESTED. THE UNIT DID NOT SLIP BUT FAILED TO SLIP AT THE 75 POUND SLIP TEST (5C). ROOT CAUSE IS UNDETERMINED; HOWEVER, THE BASE UNIT SHOULD BE INSPECTED AT 1/2 YEAR INTERVALS BY AN INTEGRA NEUROSPECIALIST PER THE INSTRUCTIONS FOR USE. THE BASE UNIT SHOULD BE SENT BACK TO INTEGRA REPAIRS DEPARTMENT FOR DETAILED INSPECTION AND SERVICING AT YEARLY INTERVALS.

    Description of Event or Problem · 1

    THE PATIENT WAS PRONE IN PIN HEADREST. DURING THE PROCEDURE, THE MAYFIELD SLIPPED CAUSING THE PATIENT'S CHIN TO REST ON THE BED. THE SURGEON THINKS THAT THE MAYFIELD WAS NOT HOLDING POSITION. THERE WAS NO PATIENT INJURY. REVISION/MEDICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO DELAY IN SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456661 ¿MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD¿ ¿COMPOSITE SERIES¿ FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1