BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTRAPHLEX IPJ

    MDR report key: 756900 · Received August 31, 2006

    Report

    Report Number
    2027754-2006-00008
    Event Type
    Injury
    Date Received
    August 31, 2006
    Report Date
    August 31, 2006
    Manufacturer
    OSTEO MED
    Product Code
    KWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT EXPLANT, THE IPJ IMPLANT IN 2ND RAY WAS BROKEN. THE IMPLANT IN 3RD RAY WAS FINE - DOCTOR BROKE WHEN REMOVING IT. NOT SURE WHICH LOT USED IN 2ND RAY. NO ANOMALIES IN DHR. REVIEW OF COMPLAINT DATABASE SHOWS NO OTHER COMPLAINTS FOR THESE LOTS. LAST COMPLAINT FOR THIS PART NUMBER REC'D IN 2004. DURING CONVERSATION WITH DOCTOR, HE STATED HE DID NOT BELIEVE THE IMPLANT WAS FAULTY. HE THOUGHT IT MORE LIKELY PT HAD STUBBED FOOT DUE TO HER LOSS OF SENSATION, RESULTING IN IMPLANT DAMAGE LABELING STATES PRODUCT IS NOT DESIGNED TO WITHSTAND EXCESSIVE FORCES. LOTS: 1007773, EXPIRATION DATE: 2009.

    Description of Event or Problem · 1

    PT UNDERWENT IMPLANT OF 2ND AND 3RD RAY IN 2006 AS TREATMENT OF HAMMERTOES. INITIAL HEALING WENT WELL. PT WAS COMPLIANT WITH FOOTWEAR. INITIAL X-RAYS OK. ABOUT 4-6 WEEKS POST-OP, PT BEGAN TO COMPLAIN ABOUT "PAINFUL HARDWARE". DR EXPLANTED BOTH PRODUCTS IN THREE MONTHS. PT HAD ARTHROPLASTY. PT CURRENTLY DOING VERY WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAPHLEX IPJ INTER PHALANGEAL STABILIZATION ROD KWH OSTEO MED 360-2240 1004270

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention