BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW UNKNOWN TYPE/SIZE

    MDR report key: 11694416 · Received April 20, 2021

    Report

    Report Number
    3012447612-2021-00124
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 23, 2021
    Report Date
    July 28, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION WAS ENTERED IN ERROR IN H3; THERE ARE NO CHANGES FROM THE INITIAL REPORT. CORRECTION IN H1. ADDITIONAL INFORMATION: H6: COMPONENT CODES, TYPE OF INVESTIGATIONS, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: PRODUCT NOT RETURNED AND PHOTOS WERE NOT PROVIDED, SO A DEVICE EVALUATION COULD NOT BE PERFORMED. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO TORQUE HANDLE WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES, RESULTING IN THE CLOSURE TOP BEING UNDER TORQUED. DHR REVIEW DHRS WERE UNABLE TO BE REVIEWED SINCE THE LOT NUMBERS ARE NOT KNOWN AT THIS TIME. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SET SCREWS WERE LOOSENED AT THE BOTTOM OF A PREVIOUSLY IMPLANTED CONSTRUCT AND A REVISION SURGERY WAS SCHEDULED TO OCCUR. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THIS IS REPORT 2 OF 3 FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: POLARIS SPINAL SYSTEM -TRANSLATION SCREW OR VITALITY SPINAL FIXATION SYSTEM. PMA/510(K) NUMBER: SIMILAR TO K150896 OR K140123. 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 3012447612-2021-00123 TO 3012447612-2021-00125.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SET SCREWS WERE LOOSENED AT THE BOTTOM OF A PREVIOUSLY IMPLANTED CONSTRUCT AND A REVISION SURGERY WAS SCHEDULED TO OCCUR. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT PROVIDED. THIS IS REPORT 2 OF 3 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593525 PEDICLE SCREW UNKNOWN TYPE/SIZE SEE H10 NKB ZIMMER BIOMET SPINE INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R