BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM DI POLYAXL SCRW 7 X 50MM

    MDR report key: 2925128 · Received January 22, 2013

    Report

    Report Number
    1526439-2013-11297
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 13, 2012
    Report Date
    May 8, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED PEDICLE SCREW FOUND BREAKAGE OCCURRED AT THE TRANSITION ZONE FROM THE SCREW POLYAXIAL BALL AND THE SCREW SHANK. A REVIEW OF THE DHR FOUND THERE WERE NO ISSUES IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. SEM ANALYSIS WAS PERFORMED ON THE BROKEN SCREW. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE, THE ANALYSIS CONCLUDED THAT THE FRACTURED SURFACE EXHIBITED SMOOTH AND GRAINY/ROUGH REGIONS, WHICH ARE ALSO INDICATIVE OF A FATIGUE FAILURE. A COMPLAINT TREND ANALYSIS REVIEW FOUND NO OBSERVED COMPLAINT TRENDS FOR ISSUES OF THIS NATURE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS TWO PEDICLE SCREWS BROKE AT S1 AFTER DORSAL STABILIZATION OF AN L5 VERTEBRAL BODY FRACTURE WITH ANTERIOR CORPECTOMY OBELISK (NON DEPUY SYNTHES SPINE DEVICE). THE FIRST SURGERY WAS FOR DORSAL STABILIZATION AT L4 S1 AND VERTEBRAL BODY REPLACEMENT WITH TITANIUM EXPANDABLE DEVICE. REVISION SURGERY WAS PERFORMED AND THE BROKEN SCREWS WERE REMOVED. THE AFFILIATE HAS BEEN REMINDED OF THE NEED TO REPORT ADVERSE EVENTS WITHIN TWENTY FOUR HOURS OF BECOMING AWARE OF THE EVENT. SEE MFG MEDWATCH REPORT# 1526439-2013-11299 FOR THE OTHER PEDICLE SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30570 EXPEDIUM DI POLYAXL SCRW 7 X 50MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ANGBZ9

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention