BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VUELOCK 5.0MM X 16MM SCREW

    MDR report key: 5721470 · Received June 13, 2016

    Report

    Report Number
    3004485144-2016-00114
    Event Type
    Injury
    Date Received
    June 13, 2016
    Report Date
    May 16, 2016
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    KWQ
    PMA / PMN Number
    PK001794
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. SUPPLEMENTAL REPORT FOUR OF FOUR FOR THE SAME EVENT; SEE ALSO 3004485144-2016-00111-1 THROUGH 3004485144-2016-00113-1.

    Additional Manufacturer Narrative · 1

    THE RETURNED SCREW WAS VISUALLY AND MECHANICALLY EXAMINED. IT WAS CONFIRMED TO MEET SIZE SPECIFICATIONS. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE COMPLAINT CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT FOUR OF FOUR FOR THE SAME EVENT; SEE ALSO 3004485144-2016-00111, 00112, AND 00113.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THAT WHEN THE SURGEON INSERTED SCREWS IN A PLATE, THE SCREW HEADS DIDN'T GET OVER THE LOCKING RING. THE SURGEON GAVE UP USING THE SCREWS SO THICKER/LONGER SCREWS WERE USED. HOWEVER, THE GRAFTED BONE WAS OUT OF PROPER POSITION, SO THE PLATE AND ALL SCREWS WERE REMOVED. AFTER THAT, HE USED THE PLATE WITH OTHER THICKER/LONGER SCREWS TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375441 VUELOCK 5.0MM X 16MM SCREW SCREW KWQ BIOMET SPINE - BROOMFIELD N/A 225920

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R