BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERLING INTERFERENCE SCREW HT 10 X 20 MM

    MDR report key: 2624237 · Received February 5, 2010

    Report

    Report Number
    3002719998-2010-00001
    Event Type
    Injury
    Date Received
    February 5, 2010
    Date of Event
    December 23, 2009
    Report Date
    January 28, 2010
    Manufacturer
    RTI BIOLOGICS
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NO DEPARTURES WERE NOTED DURING THE RE-REVIEW OF RECORDS FOR BATCH 1-090521 ASSOCIATED WITH TISSUE ID (B)(4). RESULTS: GRAFT (B)(4) PASSED ALL RELEASE CRITERIA AND MET SPECIFICATION PRIOR TO DISTRIBUTION. TO DATE, NO OTHER COMPLAINTS HAVE BEEN ASSOCIATED WITH THIS BATCH. CONCLUSION: GRAFT (B)(4) MET RTI'S SPECIFICATION AND PASSED ALL RELEASE CRITERIA. NO PT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ON (B)(6) 2010 IT WAS REPORTED TO RTI THAT THE SURGEON ATTEMPTED TO IMPLANT A STERLING INTERFERENCE SCREW FOR FIXATION DURING A REVISION SURGERY. UPON IMPLANTATION OF THE BONE SCREW, THE EDGES OF THE SCREW WERE ROUNDED OFF. THIS CAUSED THE SCREW TO BE ABOUT 5 MM TO 8 MM PROUD IN THE NOTCH OF THE KNEE. THE SURGEON REMOVED THE SCREW AND IMPLANTED A METAL SCREW. ADDITIONAL SURGERY TIME WAS REPORTED TO ADD AN HOUR OF ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING INTERFERENCE SCREW HT 10 X 20 MM XENOGRAFT HWC RTI BIOLOGICS 1-090521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other