BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLITAIRE-C 3.5X15MM SCREW

    MDR report key: 5708539 · Received June 9, 2016

    Report

    Report Number
    3004485144-2016-00107
    Event Type
    Injury
    Date Received
    June 9, 2016
    Date of Event
    May 6, 2016
    Report Date
    May 11, 2016
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    HWC
    PMA / PMN Number
    PK113796
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE: OVE (NO DROP DOWN OPTION). 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.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED 2 STRIPPED SCREWS ON A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366893 SOLITAIRE-C 3.5X15MM SCREW SCREW HWC BIOMET SPINE - BROOMFIELD N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R