BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN FRO SCREW

    MDR report key: 5952660 · Received September 15, 2016

    Report

    Report Number
    0008010177-2016-00217
    Event Type
    Injury
    Date Received
    September 15, 2016
    Date of Event
    August 18, 2016
    Report Date
    August 18, 2016
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SCREWS BACKED OUT FROM THE VARIAX DISTAL RADIUS PLATE AND THE PLATE HAD TO BE REMOVED FROM THE PATIENT. THE SURGEON FURTHER REPORTED THAT HE WAS UNSURE IF THE SCREWS HAD BEEN TIGHTENED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603765 UNKNOWN FRO SCREW IMPLANT HWC STRYKER LEIBINGER FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention