BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3799191 · Received May 8, 2014

    Report

    Report Number
    2520274-2014-11145
    Event Type
    Injury
    Date Received
    May 8, 2014
    Report Date
    April 23, 2014
    Manufacturer
    SYNTHES(USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OBERST, M., MD, PHD, HAUSCHILD, O., MD, KONSTANTINIDIS, L., MD, SUEDKAMP, N., MD, AND SCHMAL, H., MD, PHD (2012). EFFECTS OF THREE-DIMENSIONAL NAVIGATION ON INTRAOPERATIVE MANAGEMENT AND EARLY POSTOPERATIVE OUTCOME AFTER OPEN REDUCTION AND INTERNAL FIXATION OF DISPLACED ACETABULAR FRACTURES. J TRAUMA ACUTE CARE SURG, 73 (4), 950-956. THIS REPORT IS FOR AN UNKNOWN PLATE. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, OBERST, M., MD, PHD, HAUSCHILD, O., MD, KONSTANTINIDIS, L., MD, SUEDKAMP, N., MD, AND SCHMAL, H., MD, PHD (2012). EFFECTS OF THREE-DIMENSIONAL NAVIGATION ON INTRAOPERATIVE MANAGEMENT AND EARLY POSTOPERATIVE OUTCOME AFTER OPEN REDUCTION AND INTERNAL FIXATION OF DISPLACED ACETABULAR FRACTURES. J TRAUMA ACUTE CARE SURG, 73 (4), 950-956. THE AUTHORS CONDUCTED A PROSPECTIVE STUDY TO EVALUATE WHETHER INTRAOPERATIVE PROCEDURE AND/OR EARLY POSTOPERATIVE RESULTS AFTER OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF DISPLACED ACETABULUM FRACTURES ARE INFLUENCED BY THE USE OF THREE-DIMENSIONAL (3D) IMAGE INTENSIFIER IN COMBINATION WITH A NAVIGATION SYSTEM. FROM JANUARY 2004 UNTIL DECEMBER 2008, 68 PATIENTS WITH ACETABULAR FRACTURES UNDERWENT SURGERY. A CONVENTIONAL IMAGE INTENSIFIER WAS USED IN 37 PATIENTS (30 MALE, SEVEN FEMALE, AVERAGE AGE 52 YEARS) IN GROUP A; AND A 3D IMAGE-BASED NAVIGATION SYSTEM WAS USED IN 31 PATIENTS (24 MALE, 7 FEMALE, AVERAGE AGE 43 YEARS) IN GROUP B. THE FIRST PART OF THE OPERATION WAS PERFORMED IN THE SAME MANNER IN BOTH GROUPS, INCLUDING APPROACH TO THE FRACTURE, CLEANING THE FRACTURE GAPS, AND REDUCING THE FRACTURE. UPON FRACTURE REDUCTION AND STABILIZATION, AT SURGEON¿S DISCRETION, DECISION WAS MADE TO CORRECT THE REDUCTION OR, IN THE CASE OF A SATISFACTORY RESULT, TO DEFINITELY STABILIZE THE REDUCTION BY USE OF SYNTHES 3.5 MM RECONSTRUCTION PLATES AND 3.5 MM LAG SCREWS. (SEVEN PATIENTS IN GROUP B WERE ASSESSED INCAPABLE OF PARTIAL WEIGHT BEARING AND UNDERWENT PERCUTANEOUS SCREWING OF THEIR ACETABULAR FRACTURE.) THE RATE OF POSTOPERATIVE COMPLICATIONS IN GROUP A WAS 48 PERCENT AND EIGHT PERCENT IN GROUP B; COMPLICATIONS INCLUDED INFECTIONS, HEMATOMA/SEROMA, AND NEUROLOGICAL DEFICIT. THE AUTHORS SUPPORT THE USE OF NAVIGATION SYSTEMS AND A 3D IMAGE INTENSIFIER AS HELPFUL TOOLS DURING OPEN REDUCTION AND INTERNAL FIXATION OF DISPLACED ACETABULAR FRACTURES. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE AND UNKNOWN LAG SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277771 PLATE, FIXATION, BONE HRS SYNTHES(USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention