BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 14955748 · Received July 8, 2022

    Report

    Report Number
    14955748
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    April 11, 2022
    Report Date
    June 22, 2022
    Manufacturer
    STRYKER CORPORATION
    Product Code
    ERL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TIP BROKE OFF DURING PROCEDURE AND RETRIEVED BY SURGEON. UNCLEAR IF USER TECHNIQUE OR DEFECT. STRYKER PI DRIVE PLUS SPINE 004 HAS BEEN RETURNED TO STRYKER REPRESENTATIVE. NO HARM TO PATIENT. NEW DEVICE OBTAINED AND CASE CONTINUED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104107 NA DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE ERL STRYKER CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 25185 DA Unknown