BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE

    MDR report key: 9387403 · Received November 27, 2019

    Report

    Report Number
    3012447612-2019-00466
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    October 23, 2019
    Report Date
    May 15, 2020
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCREW WAS NOT RETURNED, HOWEVER, A PHOTO WAS PROVIDED. VISUAL EXAMINATION OF THE PHOTO PROVIDED SHOWS THE SHANK OF THE SCREW HAS FRACTURED. THE COMPLAINT IS CONFIRMED. WITHOUT THE RETURN OF THE DEVICE, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS A BROKEN SCREW. THERE WERE NO REPORTED IMPACTS OUTSIDE OF THE REPORTED REVISION.

    Additional Manufacturer Narrative · 1

    TYPE OF THE DEVICE: COMMON DEVICE NAME: POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM OR POLARIS SPINAL SYSTEM -TRANSLATION SCREW. PMA/510(K) NUMBER: K140123 OR K123549. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS A BROKEN SCREW. THERE WERE NO REPORTED IMPACTS OUTSIDE OF THE REPORTED REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176723 5.5 TI CANNULATED TRANSLATION SCREW, UNKNOWN SIZE SEE H10 NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R