BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEQ POLY SCREW ASSY 6.5 X 45

    MDR report key: 6242941 · Received January 11, 2017

    Report

    Report Number
    3004485144-2017-00026
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    December 1, 2016
    Report Date
    February 28, 2018
    Manufacturer
    ZIMMER BIOMET SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK131980
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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 3004485144-2017-00023 THRU 3004485144-2017-00027.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PEDICLE SCREW WAS DAMAGED DURING SURGERY. THE SCREW WAS REMOVED AND REPLACED, AND FINALIZATION OF THE CONSTRUCT WAS COMPLETED WITHOUT ANY FURTHER SURGICAL DELAY. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THERE WERE NO REPORTS OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. 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

    THE RETURNED SCREW WAS EVALUATED. THE THREADS WITHIN THE TULIP HAVE BEEN DEFORMED. THIS TYPE IS DAMAGE IS CONSISTENT WITH CROSS-THREADING THE CLOSURE TOP WITHIN THE TULIP DURING ATTEMPTED ASSEMBLY. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED AND AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THREADS OF THREE CLOSURE TOPS AND ONE PEDICLE SCREW WERE DAMAGED AND THERE WAS A SPLINTER ON A CAGE INTRAOPERATIVELY. INFORMATION REGARDING PATIENT IMPACT HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24283 SEQ POLY SCREW ASSY 6.5 X 45 SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM NKB ZIMMER BIOMET SPINE NA 84MD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention