BEUDAMED
    FDA Adverse Event Other Summary report: N

    SMARTSCREW

    MDR report key: 717757 · Received August 8, 2005

    Report

    Report Number
    9613278-2005-00014
    Event Type
    Other
    Date Received
    August 8, 2005
    Date of Event
    July 6, 2005
    Report Date
    August 5, 2005
    Manufacturer
    LINVATEC BIOMATERIALS
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A BIONX SCREW IMPLANTED A YEAR AGO, 12/2003. PATIENT CAME BACK TO THE DOCTOR TELLING HIM THAT HE WAS HAVING PAIN IN THE SAME AREA. AFTER THE DOCTOR CHECKED IT OUT THEY FOUND THAT THE SCREW DID NOT ABSORB COMPLETELY. THE SCREW WAS TAKEN OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SMARTSCREW BIOABSORBABLE BONE FIXATION DEVICE HWC LINVATEC BIOMATERIALS 224540C S0109

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention