BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 5820277 · Received July 25, 2016

    Report

    Report Number
    2520274-2016-13631
    Event Type
    Injury
    Date Received
    July 25, 2016
    Report Date
    July 13, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES). 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BERTHET, J, ET AL (2015). TITANIUM IMPLANT FAILURE AFTER CHEST WALL OSTEOSYNTHESIS. ANN THORAC SURG, 99, 1945-1952. THIS REPORT IS FOR UNKNOWN MATRIX PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: BERTHET, J, ET AL (2015). TITANIUM IMPLANT FAILURE AFTER CHEST WALL OSTEOSYNTHESIS. ANN THORAC SURG, 99, 1945-1952. FRANCE OUR OBJECTIVE WAS TO ASSESS POTENTIAL CONTRIBUTING FACTORS TO IMPLANT FAILURE (DISPLACEMENT OR RUPTURE) AFTER TITANIUM CHEST WALL OSTEOSYNTHESIS. WE RETROSPECTIVELY REVIEWED THE CLINICAL DATA AND PREOPERATIVE AND POSTOPERATIVE COMPUTED TOMOGRAPHIC SCANS OF PATIENTS UNDERGOING CHEST WALL OSTEOSYNTHESIS WITH TITANIUM IMPLANTS: THE STRATOS OR THE MATRIX FIXATION SYSTEM IN TWO EUROPEAN DEPARTMENTS OF THORACIC SURGERY. THE INDICATIONS FOR TITANIUM CHEST WALL OSTEOSYNTHESIS, THE TYPE AND NUMBER OF IMPLANTS, THE TOPOGRAPHY OF THE RECONSTRUCTION, SURGICAL SITE INFECTION, AND ROLE OF ASSOCIATED FLAP AND MESH WERE ASSESSED. BETWEEN JANUARY 2009 AND JANUARY 2013, 54 PATIENTS (29.3%) (39 MALE) WITH A MEDIAN AGE OF 44.7 + OR - 23.6 YEARS (RANGE, 7 TO 79 YEARS), TWENTY-ONE (38.8%) PATIENTS WERE YOUNGER THAN 30 YEARS UNDERWENT OSTEOSYNTHESIS AFTER SURGICAL CORRECTION OF CHEST WALL DEFORMITIES (N = 25, 46.2%) OR TO BRIDGE THE DEFECT AFTER TUMOR REMOVAL (N = 29, 53.7%). THE TOPOGRAPHY OF OSTEOSYNTHESIS WAS ANTERIOR (N = 20), LATERAL (N = 3), OR POSTERIOR (N= 1), AN AVERAGE OF 1.9 + OR - 0.9 IMPLANTS (RANGE, 1 TO 5 IMPLANTS) BEING USED. A COMBINED MESH RESTORED CONTINUITY OF THE CHEST WALL IN 15 PATIENTS, AND MUSCLE FLAP COVERAGE WAS PERFORMED IN 20. THE MEAN FOLLOW-UP TIME WAS 20.2 + OR - 8.4 MONTHS (RANGE, 3 TO 48 MONTHS). COMPLICATIONS: THIS REPORT IS FOR AN UNKNOWN MATRIX PLATE. THIS PART REFERS TO THE FOLLOWING COMPLICATIONS: ONE (1) FRACTURE OF THE PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473379 PLATE,FIXATION,BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention