BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT SCREW

    MDR report key: 4351707 · Received December 22, 2014

    Report

    Report Number
    1526439-2014-12243
    Event Type
    Injury
    Date Received
    December 22, 2014
    Report Date
    November 24, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS GENERATED FROM LITERATURE REVIEW CONDUCTED IN POST MARKET SURVEILLANCE (PMS) FOR HEALTH AUTHORITY REPORTING PURPOSES. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE PMS 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. NOT RETURNED.

    Description of Event or Problem · 1

    POST MARKET SURVEILLANCE REVIEW OF LITERATURE FOUND REPORT OF TWO SUMMIT SCREWS THAT HAD BREACHED BONE. ARTICLE TITLE: UTILITY OF EVOKED EMG MONITORING TO IMPROVE BONE SCREW PLACEMENTS IN THE CERVICAL SPINE (HOLDEFER,R.N.) PUBLICATION DATE: JUL 2013. N=2 SCREW BREACH. THE FOLLOWING MFG. MEDWATCH REPORTS ARE BEING FILED FOR THE TWO SCREWS THAT BREACHED BONE: 1526439-2014-12243, 1526439-2014-12244.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841310 SUMMIT SCREW APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention