BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

    MDR report key: 5409534 · Received February 4, 2016

    Report

    Report Number
    2520274-2016-10736
    Event Type
    Injury
    Date Received
    February 4, 2016
    Report Date
    January 21, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS METSEMAKERS, W.J. AND ET AL. (2015)."INDIVIDUAL RISK FACTORS FOR DEEP INFECTION AND COMPROMISED FRACTURE HEALING AFTER INTRAMEDULLARY NAILING OF TIBIAL SHAFT FRACTURES: A SINGLE CENTRE EXPERIENCE OF 480 PATIENTS". INJURY, INT.J. CARE INJURED 46 (2015) 740-745. THIS REPORT IS FOR UNKNOWN NAIL, UNKNOWN QUANTITY, UNKNOWN LOT. UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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 JOURNAL ARTICLE, METSEMAKERS, W.J. AND ET AL. (2015)."INDIVIDUAL RISK FACTORS FOR DEEP INFECTION AND COMPROMISED FRACTURE HEALING AFTER INTRAMEDULLARY NAILING OF TIBIAL SHAFT FRACTURES: A SINGLE CENTRE EXPERIENCE OF 480 PATIENTS". INJURY, INT.J. CARE INJURED 46 (2015) 740-745. BELGIUM ARTICLE. A RETROSPECTIVE STUDY WAS PERFORMED TO IDENTIFY RISK FACTORS FOR DEEP INFECTION AND COMPROMISED FRACTURE HEALING AFTER INTRAMEDULLARY NAILING OF TIBIAL SHAFT FRACTURES. BETWEEN JANUARY 2000 AND JANUARY 2012, 480 CONSECUTIVE PATIENTS WITH 486 TIBIA FRACTURES WERE ENROLLED IN THE STUDY. THE PURPOSE OF THE STUDY WAS TO EVALUATE RISK FACTORS OF POOR OUTCOME AFTER IM NAILING OF TIBIAL SHAFT FRACTURES. THE FOLLOWING COMPLICATIONS OCCURRED: SEVEN (7) PATIENTS (MALE) DEVELOPED DEEP INFECTION. THIS IS REPORT 2 OF 8 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN IM NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68700 ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention