BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLYAXIAL PEDICLE SCREW, UNKNOWN SIZE

    MDR report key: 12746052 · Received November 3, 2021

    Report

    Report Number
    3012447612-2021-00418
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 6, 2021
    Report Date
    December 1, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    NKB
    PMA / PMN Number
    K203507
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION PRODUCT NOT RETURNED, PHOTOS NOT PROVIDED AND X-RAYS NOT PROVIDED. DEVICE EVALUATION UNABLE TO BE PERFORMED. POTENTIAL CAUSE ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO WEAR THROUGH USE OVER TIME OR MULTIPLE STERILIZATION CYCLES. DHR REVIEW DHR WAS UNABLE TO BE REVIEWED AS LN WAS NOT KNOWN. DEVICE USE THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CLOSURE TOP MIGRATED OUT OF A PEDICLE SCREW POST-OPERATIVELY. NO TREATMENT PLANS HAVE BEEN COMMUNICATED BECAUSE THE PATIENT IS ASYMPTOMATIC. THIS IS REPORT TWO OF TWO 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 REPORT 3012447612-2021-00417.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLOSURE TOP MIGRATED OUT OF A PEDICLE SCREW POST-OPERATIVELY. NO TREATMENT PLANS HAVE BEEN COMMUNICATED BECAUSE THE PATIENT IS ASYMPTOMATIC. THIS IS REPORT TWO OF TWO FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645294 POLYAXIAL PEDICLE SCREW, UNKNOWN SIZE VITALITY SPINAL FIXATION SYSTEM NKB ZIMMER BIOMET SPINE INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown