BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS SINGLE INNER SETSCW

    MDR report key: 3232464 · Received July 18, 2013

    Report

    Report Number
    1526439-2013-21468
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 25, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK041801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED SET SCREW CONFIRMED THE THREADS HAD TORN AWAY FROM THE DEVICE. A REVIEW OF THE DHR ACKNOWLEDGED THAT NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. NO DEFINITIVE CONCLUSIONS CAN BE DRAWN AS TO THE CAUSE THE TORN THREADS. HOWEVER, THE DAMAGE SUGGESTS THAT THE SET SCREW BECAME CROSS THREADED DURING ADVANCEMENT WITHIN THE CONCOMITANT DEVICE PEDICLE SCREW. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN MIS PROCEDURE, THE THREADS OF TWO SET SCREWS BECAME DEFORMED DURING ADVANCEMENT. AS A RESULT THE SET SCREWS COULD NOT BE ASSEMBLED TO MATING PEDICLE SCREW. ALSO, THE INNER THREADS OF THE MATING PEDICLE SCREW WERE ALSO DEFORMED. HOWEVER, RECEIPT OF THE COMPLAINT SAMPLES ON (B)(4) 2013 FOUND THREADS HAD BEEN TORN FROM THE SET SCREWS AND NOT SIMPLY DEFORMED AS REPORTED. CONCOMITANT DEVICE: PEDICLE SCREW, CATALOG NUMBER UNKNOWN. SEE MFG MEDWATCH REPORT NO. 1526439-2013-21467 FOR THE FIRST SET SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333152 MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ALLCR4

    Patients

    Seq Age Sex Outcome Treatment
    1