BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 5031719 · Received August 26, 2015

    Report

    Report Number
    3004608878-2015-00227
    Event Type
    Injury
    Date Received
    August 26, 2015
    Date of Event
    July 31, 2015
    Report Date
    July 31, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PRE-AMEND
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA COMPLETED ITS INTERNAL INVESTIGATION (B)(6) 2015, THE INVESTIGATION INCLUDED: METHOD: DHR REVIEW REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. VISUAL EXAMINATION RESULTS: DHR REVIEW FOR PINS INVOLVED IN THIS CASE: DEVICE HISTORY RECORD REVIEWED FOR PRODUCT ID A1072 LOT # 1152300 MANUFACTURED ON JUNE 23, 2015 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THESE PINS PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. NO SERVICE HISTORY. DHR REVIEW FOR A1059: THIS DEVICE WAS MANUFACTURED ON JUNE 30, 2010 AND A REVIEW OF DHRS CONTAINING LOT CODE 104 SHOWED THAT THE FOLLOWING LOTS PASSED THE REQUIRED INSPECTION POINTS WITHOUT MRRS OR VARIANCES. THERE IS NO SERVICE HISTORY FOR THIS DEVICE. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. THE RETURNED UNIT PASSED ALL SPECIFIC FUNCTIONAL TESTING REQUIREMENTS, EXCEPT FOR THE LOCK HAVING ROTATIONAL MOVEMENT, WHEN UNIT IS PROPERLY POSITIONED AND PUT UNDER PRESSURE UNIT WOULD NOT HAVE SLIPPED. UPON DISASSEMBLY REPAIR NOTED THE INDEX KNOB AND THE LOCK WILL NEED NEW COMPONENTS ADDED TO REPLACE WORN INTERNAL PARTS; THIS WOULD NOT HAVE CAUSED A SLIPPAGE. CONCLUSION: IN SUMMARY, THE RETURNED UNIT PASSED ALL FUNCTIONAL TESTING REQUIREMENTS, HOWEVER GENERAL MAINTENANCE IS REQUIRED AS THIS DEVICE WAS MANUFACTURED IN 2010 WITH NO PRIOR SERVICE HISTORY. LASTLY, A MAYFIELD PATIENT POSITIONING CHART HAS BEEN PROVIDED TO THE CUSTOMER AS A REFRESHER TOOL.

    Description of Event or Problem · 1

    THE PATIENT HAD TWO LACERATIONS CAUSED BY TWO MAYFIELD PINS ON LEFT SIDE OF THE SCALP ABOVE THE EAR, BOTH 3 CENTIMETER LONG. THE INCIDENT HAPPENED WHILE THEY WERE POSITIONING THE PATIENT IN THE PRONE POSITION FOR A LEFT C6-C7 FORAMINOTOMY AND DISCECTOMY, WHEN THEY WERE ABOUT TO FIX THE SKULL CLAMP PERMANENTLY TO THE BASE. THE OPERATION WENT AHEAD AS PLANNED EXCEPT FOR THE HALF AN HOUR DELAY WHEN THE DOCTOR NEEDED TO STITCH THE LACERATIONS. THE PATIENT WAS ALRIGHT AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564785 MAYFIELD MODIFIED SKULL CLAMP N/A HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R