BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM PRE-CUT HEX END ROD, 5.5X480MM, TI

    MDR report key: 2911000 · Received January 11, 2013

    Report

    Report Number
    1526439-2013-10833
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 28, 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

    NO CONCLUSIONS CAN BE MADE. VISUAL EXAMINATION OF EXPLANTED DEVICES FOUND NO ANOMALIES THAT COULD BE ATTRIBUTED TO CONSTRUCT LOOSENING. WEAR THAT WAS NOTED ON BOTH RODS AND THE CONCOMITANT DEVICE SET SCREWS IS A RESULT OF THE RODS IMPINGING ON THE SETSCREWS AFTER THE SLIPPAGE OCCURRED. A REVIEW OF THE DHR IDENTIFIED NO ISSUES IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THE RODS AND CONCOMITANT DEVICES THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. A REVIEW OF THE COMPLAINT TREND ANALYSIS IDENTIFIED NO OBSERVED 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 PATIENT WITH SPONDYLOLISTHESIS AT L4 RECEIVED EXPEDIUM CONSTRUCT IN (B)(6) 2012. GOOD REPOSITION. PATIENT REPORTED PAIN IN (B)(6) 2012. LOOSENING OF FIXATION WAS DIAGNOSED. SET SCREWS WERE STILL LOCKED IN POSITION WHILE CRANIAL PART OF RODS WERE LYING BESIDE THE SCREW HEADS. THIS MEDWATCH REPORT IS BEING FILED FOR THE TWO RODS, BOTH CATALOG# 179762480, LOT BDFY9SP. OTHER DEVICES INCLUDED WITHIN THE CONSTRUCT: EXPEDIUM SI POLY EXT TAB SCREWS, 179732650, QTY = 4 EXPEDIUM SI SINGLE INNER SET SCREWS, 197902000, QTY = 4

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16258 EXPEDIUM PRE-CUT HEX END ROD, 5.5X480MM, TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE BDFY9SP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention