BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4 X 5.0MM SELF TAPPING SCREW

    MDR report key: 6675842 · Received June 28, 2017

    Report

    Report Number
    3012447612-2017-00199
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Report Date
    August 8, 2017
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NQW
    PMA / PMN Number
    PK100805
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED SCREWS FROM THE SAME LOT WERE EXAMINED. THE COLOR WAS FOUND TO MEET SPECIFICATIONS. THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    DEVICE PRODUCT CODE: NQW. 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. REFERENCE REPORTS 3012447612-2017-00187 AND 3012447612-2017-00189 THRU 3012447612-2017-00199.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 12 SCREWS APPEARED TO BE THE WRONG COLOR UPON RECEIPT. THE SCREWS SHOULD BE GREEN, BUT APPEARED TO BE YELLOW. THERE WAS NO SURGERY OR PATIENT ASSOCIATED WITH THIS EVENT. THIS IS REPORT TWELVE OF TWELVE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456158 2.4 X 5.0MM SELF TAPPING SCREW GALLERY LAMINOPLASTY FIXATION SYSTEM NQW ZIMMER BIOMET SPINE INC. NA B028

    Patients

    Seq Age Sex Outcome Treatment
    1