BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPROCURE SINUS TARSI IMPLANT

    MDR report key: 3926651 · Received June 18, 2014

    Report

    Report Number
    3004993707-2014-00004
    Event Type
    Injury
    Date Received
    June 18, 2014
    Manufacturer
    GRAHAM MEDICAL TECHNOLOGIES LLC (DBA GRAMEDICA)
    Product Code
    HWC
    PMA / PMN Number
    K042030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT'S FATHER SENT HIS COMPLAINT VIA EMAIL IN (B)(6). GRAMEDICA TRIED TO OBTAIN ADDITIONAL INFO FROM THE COMPLAINANT VIA EMAIL AND PHONE ON FOUR (4) SEPARATE OCCASIONS: THE 1ST ATTEMPT BY EMAIL: FRIDAY, ON (B)(4) 2014, 9:26 AM, NO RESPONSE. THE 2ND ATTEMPT BY EMAIL: FRIDAY, ON (B)(4) 2014, 11:16 AM, NO RESPONSE. THE 3RD ATTEMPT BY PHONE V: FRIDAY, ON (B)(4) 2014, 12:03 PM, NO RESPONSE. THE 4TH ATTEMPT BY EMAIL: THURSDAY, ON (B)(4) 2014, 11:07 AM, NO RESPONSE. OUR ATTEMPTS DID NOT RESULT IN ANY NEW INFO. TO DATE, OUR ITALY DISTRIBUTION IS NOT AWARE OF ANY COMPLAINTS. THEREFORE, WITHOUT DETAILS, SUCH AS; DEVICE INFO (SIZE, LOT AND EXPIRATION DATE), PHYSICIAN NAME, FACILITY NAME/ LOCATION, SURGERY DATE OR THE CURRENT STATUS OF THE PT. CONCLUSION, GRAMEDICA CANNOT INVESTIGATE ANY FURTHER AND WILL CONSIDER THIS OUR INITIAL AND FINAL REPORT.

    Description of Event or Problem · 1

    INQUIRY RECEIVED BY EMAIL, IN (B)(6): "HO FATTO INTERVENTI DI PIEDI PIATTI A MIO FIGLIO, E STATA IMPIANTATA UNA VITE DELLA VOSTRA DITTA, ORA PER COMPLICAZIONI DOBBIAMO TOGLIERLA, MA NON ABBIAMO IL KIT NECESSARIO, DOVE POSSIAMO RIVOLGERE I IN (B)(6)????". GOOGLE TRANSLATION: I MADE SPEECHES OF FLAT FEET TO MY SON, WAS IMPLANTED A SCREW OF YOUR FIRM, WE MUST REMOVE THE COMPLICATIONS NOW, BUT WE DO NOT HAVE THE NECESSARY KIT, WHERE WE CAN EXTEND IN (B)(6)????".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356778 HYPROCURE SINUS TARSI IMPLANT SUBTALAR IMPLANT HWC GRAHAM MEDICAL TECHNOLOGIES LLC (DBA GRAMEDICA)

    Patients

    Seq Age Sex Outcome Treatment
    1