BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD

    MDR report key: 3792041 · Received April 22, 2014

    Report

    Report Number
    3792041
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 25, 2014
    Report Date
    April 22, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORP
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    WHEN SURGICAL DRAPE CAME OFF, PHYSICIAN NOTED 5CM LACERATION FROM MAYFIELD PIN SITE. PIN SLIPPED; LACERATION WAS WASHED OUT. THIS FACILITY HAS HAD SEVERAL SIMILAR EVENTS WITH THIS TYPE OF DEVICE. EDUCATION HAS BEEN PROVIDED TO STAFF THAT USE AND APPLY THE DEVICE BY THE MANUFACTURER. IT IS UNCLEAR WHY THESE EVENTS CONTINUE TO OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243333 MAYFIELD HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL INTEGRA LIFESCIENCES CORP A-1108 *
    243334 MAYFIELD HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL INTEGRA LIFESCIENCES CORP 306A *
    243335 MAYFIELD HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL INTEGRA LIFESCIENCES CORP 1462395 *
    243336 MAYFIELD HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP) HBL INTEGRA LIFESCIENCES CORP 124 *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR INTEGRA IDENTIFIERS: 124, US PAT. 6,629,982.| CONSOLIDATED DEVICE IDENTIFIERS: INTEGRA MAYFIELD| #A-1108 RATCHET ARM (SINGLE PIN) #306A RATCHET TEN| ARM-UCLA #308, OTHER ETCHED #S:1359521, 13608449| 1462395 INTREGRA#ILS USA 051 MAYFIELD 2 PIN SWIVEL| TENTION KNOB ETCHED# AUG 1995 RATCHET ETCHED#