BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRS SCREW 18MM L X 3.0MM D

    MDR report key: 3782057 · Received April 30, 2014

    Report

    Report Number
    0001825034-2014-03366
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 26, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    HWC
    PMA / PMN Number
    PK062352
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. PRODUCT IS BEING RETURNED TO MANUFACTURER, BUT HAS NOT YET BEEN RECEIVED. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SENT TO THE FDA. THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. LOT NUMBER AND EXPIRATION DATE - UNKNOWN, MANUFACTURE DATE ¿ UNKNOWN.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF RETURNED DEVICE WAS INCONCLUSIVE. DURING THE EVALUATION, IT WAS NOTED THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT A METATARSAL OSTEOTOMY ON (B)(6) 2014. DURING THE PROCEDURE, THE HEAD OF THE FRS SCREW CRACKED. THE SCREW WAS REMOVED AND ANOTHER IMPLANTED WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260574 FRS SCREW 18MM L X 3.0MM D SCREW, FIXATION, BONE HWC BIOMET ORTHOPEDICS N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R