BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD 4TH BLADE 3MM OFFSET

    MDR report key: 5700807 · Received June 6, 2016

    Report

    Report Number
    3004485144-2016-00099
    Event Type
    Injury
    Date Received
    June 6, 2016
    Date of Event
    May 6, 2016
    Report Date
    December 5, 2016
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED, A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE PRODUCT EVALUATION. REPORT ONE OF TWO FOR THE SAME EVENT, SEE ALSO 3004485144-2016-00100.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EXAMINED. THE TOP WAS FOUND BENT; THE COMPLAINT IS CONFIRMED. HOWEVER, THE CAUSE OF THE ISSUE CANNOT BE DETERMINED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN SUFFICIENT INSTRUCTIONS ON DEVICE USAGE.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED BROKEN AND BENT RETRACTORS DURING SURGERY. THE RETRACTOR ATTACHMENT BENT. THE TIP OF THE RETRACTOR BROKE OFF ABOUT ONE INCH AS THE DOCTOR WAS SECURING IT. THE DOCTOR WAS ABLE TO RETRIEVE THE BROKEN PIECE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355943 ROD 4TH BLADE 3MM OFFSET RETRACTOR GAD BIOMET SPINE - BROOMFIELD N/A TU00073

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R