BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4 X 5.0MM SELF TAPPING SCREW

    MDR report key: 6618530 · Received June 7, 2017

    Report

    Report Number
    3012447612-2017-00187
    Event Type
    Malfunction
    Date Received
    June 7, 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

    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.

    Additional Manufacturer Narrative · 1

    THE RETURNED SCREWS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW APPEARED TO BE THE WRONG COLOR UPON RECEIPT. THE SCREW SHOULD BE GREEN, BUT APPEARED TO BE YELLOW. THERE WAS NO SURGERY OR PATIENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397969 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