BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3884912 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-11977
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    December 22, 2013
    Report Date
    June 5, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LITERATURE CITATION: QIU, X., ET AL (2014). LOCKING PLATE AS A DEFINITIVE EXTERNAL FIXATOR FOR TREATING TIBIAL FRACTURES WITH COMPROMISED SOFT TISSUE ENVELOP. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 134: 383-388. THIS REPORT IS FOR UNKNOWN SCREWS, QUANTITY UNKNOWN. 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 QIU, X., ET AL (2014). LOCKING PLATE AS A DEFINITIVE EXTERNAL FIXATOR FOR TREATING TIBIAL FRACTURES WITH COMPROMISED SOFT TISSUE ENVELOP. ARCHIVES OF ORTHOPAEDIC AND TRAUMA SURGERY, 134: 383-388. THE PURPOSE OF THE STUDY WAS TO EVALUATE THE OUTCOME OF USING A LOCKING PLATE AS A DEFINITIVE EXTERNAL FIXATOR FOR TREATING TIBIAL FRACTURES WITH COMPROMISED SOFT TISSUE ENVELOP. THE STUDY INVOLVED 12 TIBIAL FRACTURE PATIENTS (9 MEN, 3 WOMEN) BETWEEN JANUARY 2010 AND SEPTEMBER 2011 AND PATIENTS WERE TREATED AT THE AUTHOR¿S INSTITUTION (CHINA). IN EACH PATIENT, THE TIBIA WAS REDUCED AND ALIGNED USING INDIRECT OR DIRECT METHODS. AFTER REDUCTION AND LIMITED FIXATION OF THE FRAGMENTS, A LOCKING PLATE WAS APPLIED AS AN EXTERNAL FIXATOR. THREE TO FIVE SCREWS WERE PLACED IN BOTH ENDS OF THE FRACTURES TO ENSURE SECURE FIXATION. A SYNTHES PROXIMAL LATERAL TIBIA LOCKING COMPRESSION PLATE (LCP) OR A COMPETITOR'S PROXIMAL LATERAL TIBIA LCP WAS USED FOR PROXIMAL TIBIAL FRACTURES; THE SYNTHES ANTEROLATERAL DISTAL TIBIA LCP OR A COMPETITOR'S ANTEROLATERAL DISTAL TIBIA LCP WAS USED FOR DISTAL TIBIAL FRACTURE, AND SYNTHES DISTAL FEMUR LCP OR A COMPETITOR'S DISTAL FEMUR LCP WAS USED FOR SEGMENTAL TIBIAL FRACTURE. THIS IS REPORT 2 OF 2 FOR (B)(4), FOR UNKNOWN SCREWS (QUANTITY UNKNOWN), FOR THE REPORT OF ONE 40 YEAR OLD MALE PATIENT, WHO SUSTAINED CLOSED RIGHT PROXIMAL TIBIAL FRACTURES, AND HAD STABILIZATION WITH TWO METAPHYSEAL LOCKING PLATES USED AS DEFINITIVE EXTERNAL FIXATORS. A PIN TRACT INFECTION OCCURRED 2 MONTHS AFTER SURGERY IN THIS PATIENT. THE LATERAL PLATE AND SCREWS WERE REMOVED AND A THOROUGH DEBRIDEMENT WAS PERFORMED. THE PATIENT WAS PLACED ON ORAL ANTIBIOTIC THERAPY AND THE INFECTION RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360063 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention