BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 MM CORTICAL SCREW SELF-TAPPING 36 MM LENGTH

    MDR report key: 23348257 · Received October 21, 2025

    Report

    Report Number
    0001822565-2025-03805
    Event Type
    Injury
    Date Received
    October 21, 2025
    Report Date
    May 21, 2026
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) D10: MEDICAL PRODUCTS: ITEM#: 47493500803, ONE-THIRD TUBULAR PLT 8 HOLE; LOT#: UNKNOWN. G2: FOREIGN: UNITED KINGDOM. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED IN THE PATIENT. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D10: G3, G6, H2, H6, H11. D4/D10: AS IT IS UNKNOWN WHETHER THE SCREWS CONTRIBUTED TO THE PLATE PROMINENCE, 1 REPORT IS BEING FILED FOR POTENTIAL SCREW INVOLVEMENT. ALL SCREW USAGE IS DESCRIBED BELOW FOR SECTION D4 AND D10 3.5MM CORTICAL SCREW SELF TAPPING 36MM LOT 63373615, REF 47-4835-036-01. 3.5MM CORTICAL SCREW SELF TAPPING 28MM LOT 64628363, REF 47-4835-028-01. 3.5MM CORTICAL SCREW SELF TAPPING 22MM LOT 64487013, REF 47-4835-022-01. 3.5MM CORTICAL SCREW SELF TAPPING 16MM LOT 65031719, REF 47-4835-016-01. 3.5MM CORTICAL SCREW SELF TAPPING 14MM LOT 64913101, REF 47-4835-014-01. 3.5MM CORTICAL SCREW SELF TAPPING 12MM LOT 64775561, REF 47-4835-012-01. 3.5MM CORTICAL SCREW SELF TAPPING 30MM LOT 63357954, REF 47-4835-030-01. 4.0MM CANCELLOUS SCREW FULLY THREADED 16MM LOT 64372273, REF 47-4840-016-00. 4.0MM CANCELLOUS SCREW FULLY THREADED 10MM LOT 63282069, REF 47-4840-010-00. 4.0MM CANCELLOUS SCREW FULLY THREADED 12MM LOT 6330357, REF 47-4840-012-00. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY APPROXIMATELY THREE (YEARS) AGO. SUBSEQUENTLY, THE PATIENT REPORTS PROMINENT/PAINFUL AROUND IMPLANT WHEN RUNNING LONG DISTANCE. ATTEMPT HAS BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION RECEIVED AT THIS TIME.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509931 3.5 MM CORTICAL SCREW SELF-TAPPING 36 MM LENGTH IMPLANT/TRAUMA HWC ZIMMER BIOMET, INC. 63373615

    Patients

    Seq Age Sex Outcome Treatment
    1