BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    UNKNOWN DVR PLATE

    MDR report key: 22193596 · Received June 12, 2025

    Report

    Report Number
    0001822565-2025-01877
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    March 10, 2025
    Report Date
    July 9, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THIS PRODUCT SHOULD NOT HAVE BEEN REPORTED UNDER THIS MFR NUMBER. THIS REPORT SHOULD BE VOIDED AND A CORRECTED REPORT WILL BE FILED UNDER MFR NUMBER (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). D10: MEDICAL PRODUCTS: ITEM#: UNKNOWN, UNKNOWN TRAUMA SCREW; LOT#: UNKNOWN. G2: FOREIGN: NORWAY. G2: LITERATURE: THE RATE OF MAJOR COMPLICATIONS FOLLOWING DISTAL RADIAL FRACTURES TREATED WITH ONE SPECIFIC VOLAR LOCKING PLATE: A RETROSPECTIVE STUDY OF 1,597 CONSECUTIVE CASES IN 1,564 PATIENTS OLSEN, OLE-GUNNAR ET AL. JOURNAL OF HAND SURGERY, VOLUME 0, ISSUE 0, HTTPS://DOI.ORG/10.1016/J.JHSA.2025.01.022. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL SURGERY ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT UNDERWENT AN ADDITIONAL SURGERY DUE TO INFECTION ON AN UNKNOWN DATE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361910 UNKNOWN DVR PLATE IMPLANT/TRAUMA HWC ZIMMER BIOMET, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H SEE H11 NARRATIVE.