BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD

    MDR report key: 14464191 · Received May 20, 2022

    Report

    Report Number
    3012447612-2022-00148
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 28, 2022
    Report Date
    May 25, 2022
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    UDI-DI
    00889024007444
    PMA / PMN Number
    K150896
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. REFERENCE REPORTS 3012447612-2022-00147 THROUGH 3012447612-2022-00149.

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN D4: UDI NUMBER AND H3. ADDITIONAL INFORMATION IN H4 AND H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE. A FUNCTIONAL INSPECTION WAS PERFORMED WITH A SET SCREW STARTER (07.02119.001 LOT 102938) AND FOUND THAT THE TWO CONNECTORS WITH LOT NUMBER P141383 HAVE ONE SCREW THAT CONTINUOUSLY TURNS WHILE THE OTHER END DOES TIGHTEN AS EXPECTED. NEITHER SCREW ON THE CONNECTOR WITH LOT NUMBER W724491 TIGHTEN. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO THE SCREWS BEING TURNED THROUGH GETTING STUCK OR CROSS-THREADED. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMVIE CONTROL. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE VITALITY CONNECTORS STRIPPED INTRA-OPERATIVELY; THE SCREW DRIVER KEPT TURNING WITH ALL THREE. THEY WERE EACH REMOVED AND REPLACED WITH A FOURTH CONNECTOR TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THREE VITALITY CONNECTORS STRIPPED INTRA-OPERATIVELY; THE SCREW DRIVER KEPT TURNING WITH ALL THREE. THEY WERE EACH REMOVED AND REPLACED WITH A FOURTH CONNECTOR TO COMPLETE THE PROCEDURE WITHOUT PATIENT IMPACTS. THIS IS REPORT TWO OF THREE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1521598 ADJUSTABLE TRANSVERSE CONNECTOR ASSEMBLIES 33-36 WIDE X 5.5 MM ROD VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA P141383 00889024007444

    Patients

    Seq Age Sex Outcome Treatment
    1 Female