BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOP LOADING POLY SCREW ASSEMBLIES 6.5X45MM

    MDR report key: 22577293 · Received July 23, 2025

    Report

    Report Number
    3012447612-2025-00275
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ZIMMER BIOMET SPINE, INC.
    Product Code
    NKB
    UDI-DI
    00889024002050
    PMA / PMN Number
    K150896
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 0

    H3: "DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN" IS ERRONEOUS AND NO LONGER APPLIES. THE DEVICE WAS EVALUATED. H6: ADDITIONAL METHOD CODE: 4109 CORRECTIONS IN H3. ADDITIONAL INFORMATION IN H6: INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE RETURNED DEVICE MATCHES THE INFORMATION IN THE COMPLAINT FILE AND WAS EXAMINED. VISUAL INSPECTION REVEALED THE PACKAGE IS SEALED WITH THE LABEL STATING PART NUMBER 07.02000.075 LOT P141390, HOWEVER THE PACKAGE CONTAINS A CONNECTOR (07.02048.003 LOT P141390). ROOT CAUSE: THIS EVENT COULD BE ATTRIBUTED TO AN ERROR MADE DURING THE BAG AND TAG RELABELING PROCESS. DHR REVIEW: THE DHR WAS REVIEWED. THERE ARE NO INDICATIONS OF MANUFACTURING ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT AND THE DEVICE WAS LIKELY CONFORMING WHEN IT LEFT HIGHRIDGE¿S CONTROL. THE BAG AND TAG DHR SHOWS THAT THE LABELS WERE PRINTED FOR VITALITY 6.5 X 45 LIGHT BLUETOP LOADING POLY SCREW ASSEMBLIES (PN 07.02000.075, LN P141390). DEVICE USAGE: 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

    A DISTRIBUTOR REPORTED THAT THEY RECEIVED A SEALED PACKAGE FOR A 6.5X45MM SCREW WHICH INSTEAD CONTAINED A CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED THAT THEY RECEIVED A SEALED PACKAGE FOR A 6.5X45MM SCREW WHICH INSTEAD CONTAINED A CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2724971 TOP LOADING POLY SCREW ASSEMBLIES 6.5X45MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ZIMMER BIOMET SPINE, INC. NA P141390 00889024002050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown