BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPEN IMPLANT CLOSURE TOP

    MDR report key: 6974461 · Received October 24, 2017

    Report

    Report Number
    3012447612-2017-00581
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 30, 2017
    Report Date
    August 12, 2021
    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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IN D9, G1, AND H3. ADDITIONAL INFORMATION IN A5, D6, D8, AND H6. DEVICE EVALUATION: VISUAL INSPECTION REVEALED THE EIGHT RETURNED DEVICES WITH LOT NUMBER 86FP, SEVEN HAVE DAMAGED THREADS AND ONE HAS A STRIPPED HEX. THE TWO RETURNED WITH LOT NUMBER 86FM HAVE DAMAGED THREADS. THE ONE RETURNED WITH LOT NUMBER 84GD HAS A STRIPPED HEX. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO OFF-AXIS FORCES APPLIED DURING USE. DEVICE USE AND COMPATIBILITY THESE DEVICES ARE USED FOR TREATMENT. 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 · 0

    IT WAS REPORTED THAT 11 CLOSURE TOPS WERE DAMAGED DURING SURGERY. THEY EACH WERE DAMAGED AS THEY WERE BEING ASSEMBLED INTO THE MATING PEDICLE SCREWS. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT. THIS IS REPORT FOUR OF ELEVEN FOR THIS EVENT.

    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. REFERENCE REPORTS 3012447612-2017-00578 - 3012447612-2017-00588.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE CLOSURE TOP WAS NOT RETURNED FOR EVALUATION SO NO RESULTS ARE AVAILABLE AND NO CONCLUSIONS CAN BE DRAWN. 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 11 CLOSURE TOPS WERE DAMAGED DURING SURGERY. THEY EACH WERE DAMAGED AS THEY WERE BEING ASSEMBLED INTO THE MATING PEDICLE SCREWS. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT. THIS IS REPORT FOUR OF ELEVEN FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752889 OPEN IMPLANT CLOSURE TOP SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE INC. NA 86FP

    Patients

    Seq Age Sex Outcome Treatment
    1