BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZYPHR

    MDR report key: 24710778 · Received March 30, 2026

    Report

    Report Number
    24710778
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 9, 2026
    Report Date
    March 19, 2026
    Manufacturer
    STRYKER CORPORATION
    Product Code
    HBF
    UDI-DI
    04546540716224
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE DISPOSABLE ZYPHR CRANIAL PERFORATOR (LARGE) BY STRYKER DID NOT STOP WHEN APPROPRIATE AND WENT INTO THE PATIENT'S DURA ON THE LEFT SIDE. DURA WAS TORN, BUT WAS REPAIRED DURING SURGERY. IT DID NOT PLUNGE INTO THE BRAIN TISSUE. A NEW PERFORATOR WAS OPENED FOR THE RIGHT SIDE. REF #-5100-060-001, LOT#- 25237057, EXP- 08/01/2028.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771538 ZYPHR DRILLS, BURRS, TREPHINES ACCESSORIES (COMPOUND, POWERED) HBF STRYKER CORPORATION 5100060001 25237057 04546540716224

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H