BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 7775150 · Received August 11, 2018

    Report

    Report Number
    3004608878-2018-00179
    Event Type
    Malfunction
    Date Received
    August 11, 2018
    Report Date
    July 23, 2018
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE UNIT DID NOT MEET ALL SPECIFIC FUNCTIONAL TEST; LOCK HAVING BOTH ROTATIONAL AND LATERAL MOVEMENT AND A RESIDUE BUILDUP IS PRESENT. UNIT NEED NEW COMPONENTS ADDED TO REPLACE WORN INTERNAL PARTS; GENERAL MAINTENANCE AND CLEANING REQUIRED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID 40A1059 LOT 104 MANUFACTURED 2010 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE 280 DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. THE FOLLOWING WORK ORDERS ENCOMPASS THE DEVICES MANUFACTURED WITH THIS LOT CODE: MFG. DATE WO QTY 06/23/2010 086446 20 06/17/2010 086444 25 06/08/2010 086442 25 06/02/2010 082555 25 05/24/2010 086337 30 05/18/2010 086336 30 05/11/2010 082554 30 04/29/2010 086301 31 04/27/2010 086297 32 04/14/2010 082553 32 THE REPORTED COMPLAINT WAS CONFIRMED VIA INSPECTION OF ITEM.THE LIKELY CAUSE OF THE COMPLAINT IS WEAR AND TEAR OVER TIME/ MISUSE. THE DEFINITE CAUSE CANNOT BE RELIABLY DETERMINED.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBER: 3004608878-2018-00178.

    Description of Event or Problem · 1

    THIS REPORT IS 2 OF 2. A SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT AN A1059 MAYFIELD MODIFIED SKULL CLAMP HAD A LOOSE SWIVEL LOCK. THERE WAS NO PATIENT INJURY AND NO DELAY IN SURGERY DUE TO THE PRODUCT PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO CLINICAL INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616531 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1