BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD

    MDR report key: 6668555 · Received June 26, 2017

    Report

    Report Number
    3004608878-2017-00194
    Event Type
    Injury
    Date Received
    June 26, 2017
    Report Date
    June 7, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 07/11/2017. DEVICE HISTORY RECORD REVIEWED FOR PRODUCT ID A3101 WORK ORDER 140917 SERIAL # (B)(4) MANUFACTURED ON 05/02/2016 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 LOOKBACK FROM 06/18/2015 TO 06/18/2017 FOR THIS REPORTED FAILURE USING THE KEY WORDS "THREADS " FOR PRODUCT ID A3101 SHOWS THAT NO ADDITIONAL COMPLAINTS WERE RECEIVED. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. DURING INVESTIGATION THE FOLLOWING WAS OBSERVED: EVALUATION VERIFIED CUSTOMER INFORMATION AS VALID. A SCREW OF THE SWIVEL ADAPTER IS STRONGLY DAMAGED. THE TEETH OF THE SWIVEL ADAPTER BASE ARE WORN OUT. SWIVEL BASE OF SWIVEL ADAPTER IS DAMAGED. COMPLAINT WAS CONFIRMED FOR DAMAGED THREADS. FROM THE FAILURE ANALYSIS IT APPEARS THAT THE DEVICE WAS DAMAGED BY THE USER; POSSIBLE CROSS THREADING WHICH RUINED THE THREADS. DURING THE FAILURE ANALYSIS IT WAS DECIDED TO REPLACE THE SWIVEL ASSEMBLY - PART # A3018.

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO COMPLAINTS (SAME INCIDENT, DIFFERENT PRODUCT IDS). LINKED TO MFG. REPORT NUMBERS: 3004608878-2017-00193. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS BEING SENT TO INTEGRA FOR REPAIR. ADDITIONAL INFORMATION WAS RECEIVED ON 14JUN2017, WITH THE FOLLOWING: THE THREAD OF A3059 AND A3018 WAS DAMAGED ON THEIR OWN . THE ISSUE WAS DISCOVERED DURING SURGERY, WERE IT WAS NOTICED THAT THE THREADS ARE DAMAGED FOR A3059 AND A3018. THE PATIENT WAS ASLEEP WHEN THE ISSUE WAS DISCOVERED. THE EVENT LEAD TO AN INCREASE OF SURGERY TIME OF 15 MINUTES FOR REPOSITIONING THE PATIENT. THE PATIENT HAD THREE ADDITIONAL MAYFIELD SKULL PIN MARKS. PATIENT'S AGE AND GENDER IS UNKNOWN. THEY FINISHED THE SURGERY BY CHANGING THE EQUIPMENT DURING THE SURGERY. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446989 MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD COMPOSITE SERIES FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other