BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM

    MDR report key: 3659421 · Received March 5, 2014

    Report

    Report Number
    1526439-2014-11333
    Event Type
    Injury
    Date Received
    March 5, 2014
    Report Date
    February 19, 2014
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FOLLOW-UP REPORT IS ANTICIPATED AS THE PRODUCT HAS NOT BEEN RETURNED. THE SOURCE OF THE REPORT IS THE FOLLOWING LITERATURE SOURCE: ARTICLE TITLE: THE RATE OF SCREW MISPLACEMENT IN SEGMENTAL PEDICLE SCREW FIXATION IN ADOLESCENT IDIOPATHIC SCOLIOSIS (ABUL-KASIM,K). 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

    MEDICAL SAFETY REPORTED COMPLAINTS FROM LITERATURE THAT WAS REVIEWED FOR THE POST MARKET SURVEILLANCE REPORTING. ARTICLE TITLE: THE RATE OF SCREW MISPLACEMENT IN SEGMENTAL PEDICLE SCREW FIXATION IN ADOLESCENT IDIOPATHIC SCOLIOSIS (ABUL-KASIM,K) FEB 2011. CLINICAL FINDINGS DETERMINED BY MEDICAL SAFETY AND COMPLAINT MANAGEMENT: N=2 PATIENTS REOPERATED FOR REMOVAL OF MISPLACED PEDICLE SCREW. SEE MFG MEDWATCH REPORT NO. 1526439-2014-11332 FOR THE FIRST PATIENT WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133404 EXPEDIUM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention