BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3870786 · Received June 12, 2014

    Report

    Report Number
    2520274-2014-11807
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MED WATCH SENT IN ERROR WITHOUT LITERATURE ARTICLE ATTACHED,IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    MANAGEMENT OF PUBIC SYMPHYSIS DIASTASIS WITH LOCKING PLATES: A REPORT OF 11 CASES, BY HAMAD, ABDULKADER; PAVLOU, GEORGE; DWYER, JOHNATHAN; AND LIM, JUSTIN. INJURY, INT. J. CARE INJURED 44 (2013) 947-951. THIS REPORT IS FOR AN UNKNOWN PLATE. PART NUMBER AND LOT NUMBER ARE UNKNOWN. (B)(4) - IMPARIED HEALING WAS UTILIZED TO CAPTURE TH GAPPING OF < 10 MM. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN RECEIVED FROM A LITERATURE ARTICLE; MANAGEMENT OF PUBIC SYMPHYSIS DIASTASIS WITH LOCKING PLATES: A REPORT OF 11 CASES, BY HAMAD, ABDULKADER; PAVLOU, GEORGE; DWYER, JOHNATHAN; AND LIM, JUSTIN. INJURY, INT. J. CARE INJURED 44 (2013) 947-951. THIS WAS A RETROSPECTIVE ANALYSIS OF A SINGLE CENTRE CASE SERIES BETWEEN AUGUST 2008 AND DECEMBER 2011. A TOTAL OF 11 PATIENTS; 2 FEMALE AND 9 MALE WITH A MEAN AGE OF 42 WERE INCLUDED. OUT OF THE 11 CASES ONLY 5 CASES WERE NOTED TO HAVE REPORTABLE MALFUNCTIONS. CASE 2: A 29 YEAR OLD MALE WHO WAS INJURED DUE TO A MOTORCYCLE ACCIDENT AND SUFFERED OTHER UNSPECIFIED ASSOCIATED INJURIES HAD A 4-HOLE PLATE PLACED WITH 4 LOCKING SCREWS AND NO POSTERIOR FIXATION. ELEVEN WEEKS OUT FROM SURGERY HE WAS NOTED TO HAVE LOOSENING AT THE SCREW BONE INTERVAL AND GAPPING < 10 MM. ALL PATIENTS WERE ASYMPTOMATIC AT LAST FOLLOW-UP AND NONE REQUIRED REVISION SURGERY. IN CONCLUSION THE AUTHORS FOUND THE USE OF LOCKING PLATES ACROSS THE PUBIC SYMPHYSIS TO BE SAFE WITH LOW COMPLICATION RATES DESPITE EARLY WEIGHT BEARING. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS COMPLAINT INVOLVES AN UNKNOWN PLATE. THIS IS REPORT 6 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347308 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other