BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5021683 · Received August 21, 2015

    Report

    Report Number
    2520274-2015-15380
    Event Type
    Injury
    Date Received
    August 21, 2015
    Report Date
    August 12, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CHEN, Y., DAI, H., LI, H., QIANG, M., ZHANG, K. (2015). EFFECT OF SUSTENTACULUM SCREW PLACEMENT ON OUTCOMES OF INTRAARTICULAR CALCANEAL FRACTURE OSTEOSYNTHESIS: A PROSPECTIVE COHORT STUDY USING 3D CT. INTERNATIONAL JOURNAL OF SURGERY, 19, 72-77. THIS REPORT IS FOR UNKNOWN CALCANEUS OR LOCKING 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE CHEN, Y., DAI, H., LI, H., QIANG, M., ZHANG, K. (2015). EFFECT OF SUSTENTACULUM SCREW PLACEMENT ON OUTCOMES OF INTRAARTICULAR CALCANEAL FRACTURE OSTEOSYNTHESIS: A PROSPECTIVE COHORT STUDY USING 3D CT. INTERNATIONAL JOURNAL OF SURGERY, 19, 72-77. THE PURPOSE OF THIS ARTICLE WAS TO INVESTIGATE THE POSTOPERATIVE STATUS OF THE SUSTENTACULAR SCREW AND TO EVALUATE THE EFFECT OF THE SUSTENTACULUM SCREW PLACEMENT ON THE TREATMENT OF INTRA-ARTICULAR CALCANEAL FRACTURES. 119 PATIENTS WITH INTRA-ARTICULAR CALCANEAL FRACTURES MEETING THE INCLUSION CRITERIA WERE INCLUDED IN THIS PROSPECTIVE STUDY BETWEEN APRIL 2008 AND JANUARY 2012. THE POSTOPERATIVE SUSTENTACULUM SCREW WAS DETECTED VIA RADIOGRAPHS AND CT SCANS. ACCORDING TO THE PLACEMENT OF THE SCREW, THE PATIENTS WERE DIVIDED INTO THREE GROUPS: THE SUSTENTACULUM SCREW WITH ACCURATE FIXATION (GROUP A), MARGINAL FIXATION (GROUP B), AND NONFIXATION (GROUP C). EIGHTY FIVE PATIENTS WITH A MEAN AGE OF 43.5 YEARS (RANGE, 21-72 YEARS) CONSISTING OF 31 WOMEN AND 54 MEN WERE INCLUDED. THE AVERAGE FOLLOW-UP TIME WAS 26 MONTHS (RANGE, 12-48 MONTHS). 3D-CT CONFIRMED THAT 18 CASES WERE IN GROUP A, 33 IN GROUP B, AND 34 IN GROUP C. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN CALCANEUS OR LOCKING PLATE REFERS TO WOUND NECROSIS WITH MINOR DEHISCENCE DEVELOPED IN 2 CASES OF GROUP A, 6 CASES OF GROUP B, AND 3 CASES OF GROUP C. FOR MOST CASES, THE WOUND FINALLY HEALED AFTER DAILY WOUND DRESSING. IN ADDITION, ALSO FOR THE HARDWARE WHICH WAS REMOVED THREE MONTHS LATER IN ONE PATIENT WHO SUFFERED FROM DEEP INFECTION IN GROUP B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554229 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention