BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO ADAPTER SET FOR MAYFIELD

    MDR report key: 4265050 · Received November 20, 2014

    Report

    Report Number
    1526439-2014-12106
    Event Type
    Malfunction
    Date Received
    November 20, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 28, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    IQK
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS SURGERY FOR A SPINAL CORD INJURY TOOK PLACE WITH THE USE OF MAYFIELD, ITS ADAPTER AND A HALO VEST FOR THE PATIENT. HOWEVER, DURING THE SURGERY, THERE WAS DIFFICULTY STABILIZING THE HALO ADAPTOR SET FOR MAYFIELD AND THE CONCOMITANT DEVICE 3D CROWN MAYFIELD SLIDER ASSEMBLY. THERE WAS DAMAGE TO THE THREADS OF THE HALO ADAPTOR SET FOR MAYFIELD. A SPARE PRODUCT WAS USED TO COMPLETE THE CASE. AS A RESULT IF THE DIFFICULTY, THE SURGERY WAS EXTENDED BY 90 MINUTES. BY THE SURGEON¿S OWN ACCOUNT AFTER THE SURGERY, IT WAS OBVIOUS THAT THE THREADS OF THE ADAPTER SET HAD BEEN DEFECTIVE IN THE FIRST PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754711 HALO ADAPTER SET FOR MAYFIELD ORTHOSIS, CERVICAL IQK DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 HALO VEST, CATALOG# UNKNOWN| 3D CROWN MAYFIELD SLIDER ASSY, (B)(4)