BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 TI 5.5X35MM TRANSLATION SCREW

    MDR report key: 7084749 · Received December 5, 2017

    Report

    Report Number
    3012447612-2017-00671
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    October 1, 2017
    Report Date
    May 31, 2018
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    PK140123
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE RETURNED SCREW WAS EXAMINED. ONE SIDE OF THE TULIP WAS FOUND TO HAVE FRACTURED OFF. THE CAUSE IS LIKELY ATTRIBUTED TO A MISALIGNMENT BETWEEN THE TULIP AND THE MATING CLOSURE TOP OF THE TULIP AND THE MATING ROD. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SCREW TULIP BROKE APART DURING SURGERY. THE SCREW WAS PREVIOUSLY IMPLANTED AND WAS BEING MANIPULATED DURING A REVISION SURGERY WHEN IT BROKE. IT WAS REMOVED AND REPLACED WITH AN ALTERNATIVE SCREW. THERE WERE NO KNOWN PATIENT IMPACTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864952 5.5 TI 5.5X35MM TRANSLATION SCREW POLARIS SPINAL SYSTEM -TRANSLATION SCREW NKB ZIMMER BIOMET SPINE INC. NA 2350591

    Patients

    Seq Age Sex Outcome Treatment
    1