BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN IMPLANT CLOSURE TOP

    MDR report key: 7003349 · Received November 6, 2017

    Report

    Report Number
    3012447612-2017-00617
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    October 6, 2017
    Report Date
    April 27, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    PK131980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED CLOSURE TOP WAS EVALUATED. THERE WERE NO INDICATIONS OF DAMAGE ON THE DEVICE. THE CLOSURE TOP WAS FOUND TO WORK AS EXPECTED DURING A FUNCTIONAL ANALYSIS WITH MATING PARTS. THERE WAS NO FAILURE DETECTED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION LED TO CORRECTIONS: LOT NUMBER AND UDI NUMBER. 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

    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

    A CLOSURE TOP WAS FOUND TO NOT THREAD SMOOTHLY WITH A MATING SCREW. THIS WAS FOUND DURING A ROUTINE INSPECTION AND DID NOT HAVE ANY SURGICAL OR PATIENT IMPACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781827 OPEN IMPLANT CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE INC. NA 87CS

    Patients

    Seq Age Sex Outcome Treatment
    1