BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTICAL BONE SCREW, ÿ 4X30MM

    MDR report key: 23497761 · Received November 7, 2025

    Report

    Report Number
    0009613350-2025-00870
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    October 23, 2025
    Report Date
    April 21, 2026
    Manufacturer
    ZIMMER GMBH
    Product Code
    HSB
    UDI-DI
    00889024505353
    PMA / PMN Number
    K231114
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: PROXIMAL HUMERUS, LEFT, #ITEM 47249616107, #LOT 3163113. PROXIMAL HUMERUS NAIL CAP, #ITEM 47248801000, #LOT 3208165. BLUNT TIP SCREW, #ITEM 47248604840, #LOT 3205625. BLUNT TIP SCREW, ITEM #47248604640, #ITEM 3207879. BLUNT TIP SCREW, #ITEM 47248604440, #LOT 3202505. CORTICAL BONE SCREW, #ITEM 47248613240, #LOT 3183248. THERAPY DATE: (B)(6) 2025 G2: COUNTRY REPORT SOURCE: SPAIN. ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION AND NO FURTHER INFORMATION HAS BEEN PROVIDED. AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INITIAL CLAVICLE PLATING FOR FRACTURE COMPLETED. THE PATIENT REPORTED PERSISTENT PAIN AND STIFFNESS AFTER SURGERY AT AROUND 9 MONTHS POST-OP AND THE FRACTURE WAS OBSERVED TO BE CONSOLIDATED IN GOOD POSITION SO DEVICE REMOVAL WAS RECOMMENDED. ON IMAGING NAIL PROTRUSION WAS NOTED. THE DEVICE REMOVAL PROCEDURE WAS COMPLETED ON ONE YEAR POST IMPLANTATION WITHOUT ANY KNOWN COMPLICATIONS. FURTHER DETAILS HAVE NOT BEEN PROVIDED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139932 CORTICAL BONE SCREW, ÿ 4X30MM IMPLANT, TRAUMA HSB ZIMMER GMBH 3197007 00889024505353

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| R SEE H11 NARRATIVE.