BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4011439 · Received August 14, 2014

    Report

    Report Number
    2520274-2014-13050
    Event Type
    Injury
    Date Received
    August 14, 2014
    Report Date
    July 24, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN MATRIXRIB PLATE, 1.5 MM THICKNESS, UNKNOWN PART#/LOT#. SCHULZ-DROST ET AL (2014). ELASTIC STABLE CHEST REPAIR (ESCR) AS A MEAN OF STABILIZING THE ANTERIOR CHEST WALL IN RECURRENT PECTUS EXCAVATUM WITH STERNOCOASTAL PSUEDOARTHOSIS: AN INNOVATION FIXATION DEVICE. 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE; "SCHULZ-DROST ET AL (2014). ELASTIC STABLE CHEST REPAIR (ESCR) AS A MEAN OF STABILIZING THE ANTERIOR CHEST WALL IN RECURRENT PECTUS EXCAVATUM WITH STERNOCOASTAL PSUEDOARTHOSIS: AN INNOVATION FIXATION DEVICE." THE OBJECTIVE WAS TO STUDY A SERIES OF PATIENTS WHO HAD COMPARABLE CHARACTERISTICS AND PROBLEMS AND WHO WERE SUFFERING FROM RECURRENT PECTUS EXCAVATUM (PE) AFTER PRIMARY OPEN PROCEDURE. THE RECONSTRUCTION WAS STUDIED IN A GROUP OF 20 CONSECUTIVE PATIENTS (3 FEMALE, 17 MALE, AVERAGE AGE: 25.6 YEARS) WHO UNDERWENT SURGERY IN 2011. INCLUSION CRITERION WAS A SYMPTOMATIC RECURRENCE OF PE WITH STERNOCOSTAL PSEUDOARTHROSIS FOLLOWING OPEN REPAIR. INCLUDED IN THE STUDY WERE PATIENTS WHO HAD NO OTHER DISEASE OR WHO WERE TAKING NO OTHER MEDICATION EXCEPT PAIN RELIEVERS FOR THE PAINFUL CHEST WALL DEFORMITY. PATIENTS UNDERWENT ANOTHER OPEN SURGERY WITH REVISION OF THE PSEUDOARTHROSIC STERNOCOSTAL JUNCTIONS AND SUFFICIENT MOBILIZATION OF THE ANTERIOR CHEST WALL, FOLLOWED BY AN OPEN REDUCTION AND INTERNAL FIXATION USING MATRIXRIB TITANIUM PLATES. THIS PROCEDURE CONSISTED OF ELEVATING THE ANTERIOR CHEST WALL AND FIXING THE RIBS TO THE STERNUM. MEAN OPERATION TIME WAS 3.37 HOURS FOR THE COMPLETE REVISION PERFORMED BY THE SAME SURGEON, 6 OUT OF 20 PATIENTS REQUIRED BLOOD TRANSFUSION DUE TO BLOODY EFFUSION, WHILE ONCE CASE PATIENT 3 WITH AN INJURY TO THE LEFT INTERNAL MAMMARY ARTERY REQUIRED BOTH GROSS TRANSDUSION AND REOPERATION. THE PATIENTS UNDERWENT CLINICAL AND ULTRASOUND EXAMINATION AND X-RAY RADIOGRAPHS AFTER THE OPERATION, AFTER 6 WEEKS AND AT 3 MONTH AND 12-MONTH INTERVALS. THE HALLER INDEX DETECTED BY COMPUTED TOMOGRAPHY (CT) SCAN OF RECURRENT PECTUS WAS 3.6 AND 1 YEARS AFTER ESCR SHOWED A SIGNIFICANTLY DECREASE TO 2.7. COSMETIC RESULTS WERE QUITE SATISFACTORY, WITH EXCELLENT ANATOMICAL SHAPE ACHIEVED IN 15 OUT OF 20 PATIENTS AND NEARLY NORMAL ANATOMICAL SHAPE IN THE OTHER PATIENTS. ONE CASE SHOWED PECTORAL ASYMMETRY. ALL WOUNDS SHOWED STANDARD, UNCOMPLICATED HEALING. AFTER ONE YEAR FOLLOW-UP, ONE CASE PRESENTED WITH LOOSENING OF ONE OF THE PLATE EDGES, BUT WITHOUT ANY CLINICAL SYMPTOMS. THREE MORE PATIENTS HAD A SINGLE BREAK IN THE IMPLANT: PATIENT 18 AFTER BLUNT CHEST TRAUMA CONSISTENT WITH MOTOR VEHICLE CRASH; PATIENT 5 & 6 DUE TO UNKNOWN CAUSES. PATIENT 5, WHOSE BEHAVIOR WAS NOT PROTOCOL COMPLIANT, CONSECUTIVELY SUFFERED ANOTHER RECURRING PE. DUE TO PAINFUL INSTABILITY IN COMBINATION WITH THE RECURRENT PE, THIS PATIENT HAD TO UNDERGO ANOTHER OPERATION WITHOUT FURTHER COMPLICATIONS. THIS REPORT FOR 1 DEVICE. THIS REPORT FOR UNKNOWN MATRIXRIB, 1.5MM THICKNESS, UNKNOWN PART#/LOT# AND REFERS TO ADVERSE EVENT IN PATIENT# 11: (B)(6) MALE PATIENT (LEFT PNEUMOTHORAX) . THIS IS REPORT 7 OF 16 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486893 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention