BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3994832 · Received August 8, 2014

    Report

    Report Number
    2520274-2014-12702
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 4, 2013
    Report Date
    July 11, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN LATERAL TIBIAL LCP 4.5/5 SYSTEM. DEVICE NAME: PLATE, FIXATION, BONE; HRS 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, NAIK, M., ARORA, G., TRIPATHY, S., SUJIR, P. AND RAO, S. (2013, MARCH). CLINICAL AND RADIOLOGICAL OUTCOME OF PERCUTANEOUS PLATING IN EXTRA-ARTICULAR PROXIMAL TIBIA FRACTURES: A PROSPECTIVE STUDY. INJURY INT. J. CARE INJURED, 44, 1081-1086. THE AUTHORS CONDUCTED A PROSPECTIVE COHORT STUDY TO EXAMINE THE CLINICAL AND RADIOLOGICAL OUTCOME OF PERCUTANEOUS LATERAL LOCKED PLATING USING SYNTHES DEVICE, LATERAL TIBIAL LOCKING COMPRESSION PLATE (LCP) 4.5/5 SYSTEM, IN THE TREATMENT OF PROXIMAL TIBIA FRACTURE. BETWEEN APRIL 2008 AND SEPTEMBER 2010, 47 PATIENTS (43 MALE AND FOUR FEMALE) WITH MEAN AGE OF 42 YEARS (RANGE, 20-71 YEARS) WERE TREATED; THE INJURY WAS BILATERAL IN ONE PATIENT THEREFORE A TOTAL OF 49 PROXIMAL TIBIAL FRACTURES WERE TREATED. PATIENTS WERE FOLLOWED UP AT SIX WEEKS, THREE MONTHS, SIX MONTHS AND ONE YEAR. THE AUTHORS REPORTED FOUR PATIENTS WITH DEEP INFECTION POSTOPERATIVELY WHICH NEEDED MULTIPLE DEBRIDEMENT, GENTAMYCIN BEAD APPLICATION AND PROLONGED ANTIBIOTIC THERAPY. THREE OF THESE CASES RESULTED IN NONUNION AND REQUIRED BONE GRAFTING. IMPLANTS WERE RETAINED IN ALL FOUR CASES. ONE PATIENT REPORTED HARDWARE PROMINENCE, NECESSITATING IMPLANT REMOVAL. MALUNION IN CORONAL OR SAGITTAL OR IN BOTH PLANES WERE OBSERVED IN TEN PATIENTS, SIX HAD VARUS/VALGUS (RANGE, 11 DEGREES VALGUS TO NINE DEGREES VARUS) AND FIVE PATIENTS HAD PROCURVATUM OR RECURVATUM (RANGE, 14 DEGREES PROCURVATUM TO 13 DEGREES RECURVATUM). ONE PATIENT HAD MALUNION IN BOTH PLANES. ROTATIONAL MALUNION WAS REPORTED IN TWO PATIENTS. AVERAGE SHORTENING OF ONE CENTIMETER WAS OBSERVED IN TWO PATIENTS. THIS REPORT IS FOR AN UNKNOWN LATERAL TIBIAL LCP 4.5/5 SYSTEM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467040 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention