BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW, UNKNOWN SIZE

    MDR report key: 8594973 · Received May 9, 2019

    Report

    Report Number
    3012447612-2019-00216
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    April 10, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: (RESULTS AND CONCLUSIONS) - 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 3012447612-2019-00213 THROUGH 3012447612-2019-00217.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM OR PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM. UDI NUMBER: NI. G5 510(K) NUMBER: K131980 OR K132884. 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 REPORT 3012447612-2019-00217.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A PEDICLE SCREW CONSTRUCT AFTER THE PATIENT WAS IN A CAR ACCIDENT AND COMPLAINED OF BACK AND/OR LEG PAIN. THERE WERE NO REPORTS OF DEVICE FAILURE OR MALFUNCTION, AND IT CANNOT BE DETERMINED IF THE DEVICES WERE ASSOCIATED WITH THE PAIN. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE A PEDICLE SCREW CONSTRUCT AFTER THE PATIENT WAS IN A CAR ACCIDENT AND COMPLAINED OF BACK AND/OR LEG PAIN. THERE WERE NO REPORTS OF DEVICE FAILURE OR MALFUNCTION, AND IT CANNOT BE DETERMINED IF THE DEVICES WERE ASSOCIATED WITH THE PAIN. THIS IS REPORT FOUR OF FIVE FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389613 PEDICLE SCREW, UNKNOWN SIZE SEE H10 NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization| R