BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCKING SCREW, 2.7 X 22 MM

    MDR report key: 1618270 · Received February 25, 2010

    Report

    Report Number
    1651501-2010-00009
    Event Type
    Injury
    Date Received
    February 25, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 25, 2010
    Manufacturer
    ASCENSION ORTHOPEDICS, INC.
    Product Code
    HRS
    PMA / PMN Number
    K022325
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR ONE SCREW THAT WAS USED TO SECURE THE PLATE TO THE BONE IN THE LEFT FOOT. DISCUSSION: THE PLATE FUNCTIONED AS INTENDED AS EVIDENCED BY BONE FUSION. NO EVIDENCE OF GROSS DISTORTION OR SURFACE DAMAGE THAT COULD PRODUCE UNINTENDED ANATOMIC IMPINGEMENTS WAS OBSERVED. THE CONDITION OF THE PLATE WAS SIMILAR TO THAT OF A NEW AS PACKAGED PLATE, WITH THE EXCEPTION OF MINOR HANDLING DAMAGE THAT OCCURRED DURING IMPLANTATION AND REMOVAL. CONCLUSION: THE PLATE AND SCREWS FUNCTIONED AS INTENDED. TAKEN OUT OF THE CONTEXT OF THE PT, IT IS IMPOSSIBLE TO DETERMINE IF THE PT'S EXPERIENCE OF PAIN WAS RELATED TO ANY GEOMETRIC OR SURFACE FEATURES OF THE PLATE AND SCREWS.

    Description of Event or Problem · 1

    PT COMPLAINED THAT THE PLATE AND SCREWS WERE IRRITATING HER FOOT WHEN SHE HAD HER SHOE ON. SHE HAD ASKED FOR THE DEVICE TO BE REMOVED AFTER 4 MONTHS. THE PHYSICIAN INDICATED THAT HE WAS HAPPY WITH THE RESULT. IN THE SURGERY TO REMOVE THE DEVICE, THE SURGEON INDICATED THAT THE DEVICE HAD DONE IT'S JOB IN THAT BONE FUSION WAS ACHIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING SCREW, 2.7 X 22 MM BONE FIXATION PLATE (SCREW) HRS ASCENSION ORTHOPEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization