BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSURE TOP

    MDR report key: 10141574 · Received June 11, 2020

    Report

    Report Number
    3012447612-2020-00303
    Event Type
    Injury
    Date Received
    June 11, 2020
    Date of Event
    May 26, 2020
    Report Date
    August 12, 2020
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    K150896
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D4 (LOT NUMBER).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: METHOD, RESULTS, AND CONCLUSIONS. THE RETURNED CLOSURE TOP WAS EVALUATED. THERE WAS MINOR THREAD DEFORMATION FOUND WHICH PREVENTED THE CLOSURE TOP FROM THREADING SMOOTHLY WITH A MATING SCREW DURING A FUNCTIONAL INSPECTION. HOWEVER, IT CANNOT BE DETERMINED THE DAMAGE IS THE RESULT OF CROSS-THREADING DURING INSERTION, REMOVAL, OR DAMAGE FROM BACKING OUT POSTOPERATIVELY. THE WEAR PATTERN ON THE BOTTOM OF THE SET SCREW FAVORS ONE SIDE AND DOES NOT HAVE STRONG MARKINGS, INDICATING THE CLOSURE TOP WAS NOT FULLY SEATED ON THE ROD. AN INTERNAL CAPA WAS INITIATED TO EVALUATE THE CAUSE OF THIS ISSUE. THIS INVESTIGATION FOUND THAT THE VITAL MIS EXTENDED TAB SCREW HOUSING AND TAB DESIGNS WERE MORE SUSCEPTIBLE TO CONDITIONS THAT COULD RESULT IN INADEQUATE LOCKING, SUCH AS SPLAYING, THREAD MOVEMENT, AND REDUCTION BASED ISSUES. THE SCREWS ARE THE SUBJECT OF FIELD ACTION 3012447612-05-01-2020-001-R; HOWEVER, THIS CLOSURE TOP IS NOT WITHIN THE SCOPE OF THE FIELD ACTION. THE DHR WAS REVIEWED AND THERE WERE NO MANUFACTURING-RELATED ISSUES FOUND THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE LABELING WAS REVIEWED DOES NOT APPEAR TO HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED, THAT TWO CLOSURE TOPS WERE FOUND TO HAVE MIGRATED TWO MONTHS POST-OPERATIVELY. A REVISION WAS PERFORMED TO REMOVE AND REPLACE THE CONSTRUCT WITH ALTERNATIVE DEVICES. NO ADDITIONAL PATIENT IMPACTS WERE REPORTED. THIS IS REPORT TWO OF FOUR FOR THIS EVEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO CLOSURE TOPS WERE FOUND TO HAVE MIGRATED TWO MONTHS POST-OPERATIVELY. A REVISION WAS PERFORMED TO REMOVE AND REPLACE THE CONSTRUCT WITH ALTERNATIVE DEVICES. NO ADDITIONAL PATIENT IMPACTS WERE REPORTED. THIS IS REPORT TWO OF FOUR FOR 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. REFERENCE REPORTS 3012447612-2020-00302, 3012447612-2020-00304, 3012447612-2020-00305.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO CLOSURE TOPS WERE FOUND TO HAVE MIGRATED TWO MONTHS POST-OPERATIVELY. A REVISION WAS PERFORMED TO REMOVE AND REPLACE THE CONSTRUCT WITH ALTERNATIVE DEVICES. NO ADDITIONAL PATIENT IMPACTS WERE REPORTED. THIS IS REPORT TWO OF FOUR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606221 CLOSURE TOP VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA W667291

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R