BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3999938 · Received August 11, 2014

    Report

    Report Number
    2520274-2014-12771
    Event Type
    Injury
    Date Received
    August 11, 2014
    Report Date
    July 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MEAN AGE 62 YEARS (RANGE 31-90 YEARS). 24 MALES AND 16 FEMALES. WEIGHTS NOT REPORTED. OH, J-K, ET AL. (2013). LOCKING PLATE IN PROXIMAL TIBIAL FRACTURE: A CORRELATION BETWEEN THE CORONAL ALIGNMENT OF TIBIA AND JOINT SCREW ANGLE YONSEI MED J, 54, (3):720-725. THIS REPORT IS FOR UNKNOWN LOCKING PLATES, UNKNOWN PART NUMBER AND UNKNOWN LOT NUMBER. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE ¿LOCKING PLATE IN PROXIMAL TIBIAL FRACTURE: A CORRELATION BETWEEN THE CORONAL ALIGNMENT OF TIBIA AND JOINT SCREW ANGLE¿ OH, J., ET AL, YONSEI MED J. A STUDY WAS DONE TO EVALUATE THE RELATIONSHIP BETWEEN THE ANGLE FORMED BETWEEN THE PROXIMAL MOST SCREW THROUGH THE LOCKING COMPRESSION PLATE-PROXIMAL LATERAL TIBIA (LCP PLT, SYNTHES) AND THE JOINT LINE, AND TO EVALUATE IF THIS ANGLE COULD BE USED INTRAOPERATIVELY AS AN ASSESSMENT TOOL TO DETERMINE NORMAL ALIGNMENT OF THE TIBIA IN THE CORONAL PLANE. THERE WERE TWO PARTS TO THE STUDY: IN THE FIRST PART, LCP PLT WAS APPLIED TO 30 CADAVERIC ADULT TIBIA. THE ANGLE BETWEEN THE JOINT LINE AND THE PROXIMAL MOST SCREW WAS MEASURED AND TERMED AS THE ¿JOINT SCREW ANGLE¿ (JSA). IN THE SECOND PART, 56 PROXIMAL TIBIAL FRACTURES TREATED WITH LCP PLT WERE RETROSPECTIVELY STUDIED. TWO ANGLES WERE MEASURED ON THE RADIOGRAPHS, THE MEDIAL PROXIMAL TIBIAL ANGLE (MPTA) AND THE JSA. THIRTY TIBIAL SHAFTS FROM ADULT CADAVERS (24 MALES, 16 FEMALE; MEAN AGE 62 YEARS (RANGE 31-90 YEARS) WERE USED. AN 11-HOLE LCP PLT WAS APPLIED TO THE LATERAL ASPECT OF THE PROXIMAL TIBIA. THE LCP PLT WAS APPLIED SUCH THAT THE PLATE NESTLED UP WITH THE LATERAL ASPECT OF PROXIMAL METAPHYSIS AND WAS PARALLEL TO THE AXIS OF THE TIBIAL SHAFT; THEN 2 PROXIMAL MOST LOCKING SCREWS WERE THEN PLACED. GROSS OBSERVATION WAS USED TO SEE IF ANY PART THE PLATE DID NOT FIT THE BONE SURFACE WELL. ON THE ANTEROPOSTERIOR IMAGE, THE ANGLE BETWEEN PROXIMAL TIBIAL JOINT LINE AND THE LOCKING SCREW WAS MEASURED, AND TERMED THE ANGLE AS JSA. POSITIVE AND NEGATIVE VALUES WERE DESIGNATED TO THE JSA DEPENDING ON THE SCREW TILT ON THE JOINT LINE. FIFTY-SIX CASES OF PROXIMAL TIBIAL FRACTURES THAT WERE TREATED WITH LCP PLT WERE RETROSPECTIVELY REVIEWED; 44 MALES, 12 FEMALES; MEAN AGE 52 YEARS (RANGE 30-88 YEARS. WITHIN 2 WEEKS OF INJURY, 49 FRACTURES WERE TREATED IN AN ACUTE SETTING. THERE WERE SIX NON-UNION AND ONE MALUNION OF THE PROXIMAL METAPHYSIS. THE FRESH FRACTURES WERE CLASSIFIED ACCORDING TO THE AO-OTA CLASSIFICATION. RADIOLOGIC ANALYSIS WAS DONE ON 56 PATIENTS. THE MEDIAL PROXIMAL TIBIAL ANGLE (MPTA; ANGLE MEASURED ON THE MEDIAL SIDE FORMED BETWEEN THE TIBIAL PLATEAU LINE AND THE LINE ALONG THE TIBIAL AXIS) WAS MEASURED IN BOTH THE TIBIAE ON THE POSTOPERATIVE ORTHORADIOGRAM AND THE DIFFERENCE WAS CALCULATED. MALALIGNMENT WAS DEFINED AS A DIFFERENCE OF MORE THAN 5° IN THE MPTA. THE JSA WAS MEASURED SIMULTANEOUSLY ON BOTH INTRAOPERATIVE AND POSTOPERATIVE IMAGES IN 29 CASES. THE REMAINING 27 PATIENTS, THE JSA WAS MEASURED ONLY ON THE POSTOPERATIVE ORTHORADIOGRAM. ON GROSS OBSERVATION, THE LCP PLT FIT THE LATERAL ASPECT OF THE PROXIMAL TIBIAE FAIRLY WELL. HOWEVER, IT WAS FOUND THAT THE HEAD OF THE PLATE TENDED TO STAY APART FROM THE LATERAL ASPECT OF THE LATERAL CONDYLE BY A FEW MILLIMETERS. THE CLINICAL AND RADIOGRAPHIC RETROSPECTIVE STUDY YIELDED THE FOLLOWING RESULTS. IN 49 OF THE 56 PATIENTS, THE MPTA WAS FOUND TO BE ACCEPTABLE AND WITHIN THE NORMAL RANGE (WITHIN 5° OF THE CONTRALATERAL NORMAL LIMB OR AVERAGE OF THE POPULATION). IN 7 REMAINING PATIENTS, THERE WAS MALALIGNMENT IN THE CORONAL PLANE AND THE MPTA WAS OUT OF THE NORMAL RANGE. OUT OF THE 49 PATIENTS WITH NORMAL ALIGNMENT, THE JSA WAS FOUND TO BE IN THE ACCEPT¬ABLE RANGE IN 47 PATIENTS, AND IN THE UNACCEPTABLE RANGE IN THE REMAINING 2 PATIENTS. IN THE 7 PATIENTS WITH MALALIGNMENT, THE JSA WAS UNACCEPTABLE IN 4 PATIENTS AND ACCEPTABLE IN THE REMAINING 3 PATIENTS. OUT OF THE 6 PATIENTS WITH AN ABNORMAL JSA, 4 PATIENTS SHOWED MALALIGNMENT. IT WAS CONCLUDED THAT THE JSA CAN BE USED INTRAOPERATIVELY AS A ROUGH GUIDELINE TO ASSESS THE ACHIEVEMENT OF A FINAL NORMAL ALIGNMENT IN THE CORONAL PLANE WHEN APPLYING A LCP PLT/LISS FOR FRACTURES OF THE PROXIMAL TIBIA. THIS REPORT IS AGAINST UNKNOWN LOCKING PLATES FOR 7 MALALIGNMENTS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476296 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention