BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5123625 · Received October 2, 2015

    Report

    Report Number
    2520274-2015-16386
    Event Type
    Injury
    Date Received
    October 2, 2015
    Report Date
    September 28, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. GRALA,P., KIERZYNKA, G., MACHYNSKA-BUCKO,Z (2007), SURGICAL TREATMENT OF ARTICULAR CALCANEAL FRACTURES,ORTOPEDIA TRAUMATOLOGIA REHABILITACJA,1(6); VOL.9, PP.89-97. THIS REPORT IS FOR AN UNKNOWN RECONSTRUCTION PLATE. (B)(4). 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.

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED: THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE. GRALA,P., KIERZYNKA, G., MACHYNSKA-BUCKO,Z (2007), SURGICAL TREATMENT OF ARTICULAR CALCANEAL FRACTURES,ORTOPEDIA TRAUMATOLOGIA REHABILITACJA,1(6); VOL.9, PP.89-97. DURING A 3-YEAR PERIOD (2002-2005) 23 PATIENTS (19 MEN, 4 WOMEN, 19-57 YEARS OF AGE) INVOLVING THE POSTERIOR CALCANEO-TALAR JOINT (SANDERS II AND III ACCORDING TO CT-BASED CLASSIFICATION) WERE TREATED WITH OPEN REDUCTION AND INTERNAL FIXATION OF THE CALCANEUS THROUGH AN EXTENDED LATERAL APPROACH. FIXATION WAS PERFORMED USING LAG SCREWS AND A RECONSTRUCTION PLATE (SYNTHES) TO STABILIZE THE PREVIOUSLY REDUCED POSTERIOR ARTICULAR SURFACE (PAS). INFECTIOUS COMPLICATIONS OCCURRED IN 3 (13%) PATIENTS: IN 2 CASES THEY HEALED WITH LOCAL WOUND CARE, IN 1 (4%), DESPITE REMOVAL OF THE IMPLANT (AFTER 3 MONTHS) THE PATIENT STILL HAS ULCERATION (ABOUT 1CM2) WITH MINIMAL DRAINAGE OF A SEROUS EXUDATE (CULTURE: (B)(6)). THE MOST COMMON COMPLICATION ADVERSELY AFFECTING THE FINAL OUTCOME WAS CONTRACTURE OF THE TOES WITH EXCESSIVE EXCAVATION OF THE FOOT, WHICH WAS POSSIBLY A CONSEQUENCE OF ISCHEMIA OF THE SHORT MUSCLES OF THE FOOT (6 CASES). IT WAS USUALLY ASSOCIATED WITH VARIABLE PAIN ESPECIALLY AFTER LONG PERIODS OF WEIGHT BEARING (STANDING, WALKING). THE FOLLOWING PATIENTS DEVELOPED TOE CONTRACTURE: A (B)(6) MALE WITH SANDERS TYPE II. A (B)(6) MALE WITH SANDERS TYPE II. A (B)(6) FEMALE WITH SANDERS TYPE III. A (B)(6) MALE WITH SANDERS TYPE III. A (B)(6) FEMALE WITH SANDERS TYPE III. A (B)(6) MALE WITH SANDERS TYPE II. A (B)(6) MALE WITH SANDERS TYPE III DEVELOPED TOE CONTRACTURE AND INFECTION. THIS REPORT IS 1 OF 8 FOR (B)(4), FOR AN UNKNOWN RECONSTRUCTION PLATE. INFECTIOUS COMPLICATIONS OCCURRED IN 3 (13%) PATIENTS: IN 2 CASES THEY HEALED WITH LOCAL WOUND CARE, IN 1 (4%), DESPITE REMOVAL OF THE IMPLANT (AFTER 3 MONTHS) THE PATIENT STILL HAS ULCERATION (ABOUT 1CM2) WITH MINIMAL DRAINAGE OF A SEROUS EXUDATE (CULTURE: (B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654513 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention