BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 MM 2 X 8 T PLATE LOCKING

    MDR report key: 2893945 · Received December 19, 2012

    Report

    Report Number
    2027754-2012-00015
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    August 27, 2012
    Report Date
    December 18, 2012
    Manufacturer
    OSTEOMED
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLATE, PN 333-2006, WAS IMPLANTED ON (B)(6) 2012, DUE TO A 3RD DEGREE FRACTURE OF THE METACARPAL BONE. APPROX 10 WEEKS AFTER SURGERY, AN X-RAY REVEALED FRAGMENTS DUE TO THE BROKEN PLATE. ACCORDING TO THE DOCTOR, THE PT DID NOT HAVE ANY TYPE OF ACCIDENT OR PAIN BEFORE THE X-RAY. HE FOLLOWED ALL MEDICAL INSTRUCTIONS. ON (B)(6) 2012, THE DOCTOR REMOVED THE BROKEN PLATE AND PUT IN A NEW PLATE, PN 333-2006, AND A NEW SCREW. THEY STARTED THE "KINE" AND "FLEX" EXTENSION WITH DYNAMIC FERULA FLEXORA. AFTER THE SURGERY, THERE WAS SATISFACTORY EVOLUTION WITHOUT PAIN AVO DORSAL. THE PT IS IN GOOD CONDITION. THE RETURNED PLATE HAD A CLEAN MIDDLE BREAK IN THE 3RD HOLE. ACCORDING TO THE ENGINEER, A SCREW SHOULD HAVE PROBABLY BEEN PLACED PERPENDICULAR TO THE FRACTURE. IN ADDITION, PER OUR RESIDENT EXPERT (MEDICAL DOCTOR) BASED ON THE X-RAY, THE SCREW WAS PLACED TOO CLOSE TO THE FRACTURE LINE. BASED ON STANDARD AO FRACTURE FIXATION TECHNIQUES, A MINIMUM 1-2MM SPACING SHOULD EXIST BETWEEN THE FRACTURE SITE AND NEAREST SCREW. THERE WAS ONE OTHER COMPLAINT FOR THIS PART IN THE COMPLAINT DATABASE FROM AN INTERNATIONAL DOCTOR.

    Description of Event or Problem · 1

    THE PART WAS IMPLANTED ON (B)(6) 2012 AND EXPLANTED ON (B)(6) 2012, APPROX 2.5 MONTHS AFTER IMPLANTATION DUE. IT WAS NOTED ON THE POST - OP X-RAY THAT THE PLATE HAD BROKEN. THE PLATE WAS EXPLANTED APPROX 3 MONTHS AFTER IMPLANTATION AND ANOTHER PLATE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0 MM 2 X 8 T PLATE LOCKING BONE PLATE HRS OSTEOMED 333-2006 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention