BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAY, SURGICAL, INSTRUMENT

    MDR report key: 6883878 · Received September 21, 2017

    Report

    Report Number
    2520274-2017-12316
    Event Type
    Injury
    Date Received
    September 21, 2017
    Report Date
    September 13, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    FSM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KAZDA, S; ET AL (2009) COMPARATIVE CLINICAL STUDY ASSESSING C2 DENS INJURIES TREATMENT OUTCOMES. ROZHL CHIR, (10) 554-558. THIS REPORT IS FOR AN UNKNOWN RADIAL HEAD SYSTEM (UNKNOWN QUANTITY/UNKNOWN LOT). (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; 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 SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: KAZDA, S; ET AL (2009) COMPARATIVE CLINICAL STUDY ASSESSING C2 DENS INJURIES TREATMENT OUTCOMES. ROZHL CHIR, (10) 554-558. THIS IS A RETROSPECTIVE STUDY TO COMPARE TREATMENT OUTCOMES OF C2 DENS FRACTURES FOLLOWING THEIR CONSERVATIVE OR SURGICAL MANAGEMENT, USING DIRECT OSTEOSYNTHESIS WITH CANALISED SCREWS AND THE DENS ACCESS DEVICE. THE STUDY INCLUDED 32 PATIENTS TREATED BETWEEN 1999-2006 WITH TYPE II AND II DENS INJURY. THE MEAN AGE WAS 56 YEARS (17¿83 Y.O.A.), 19 SUBJECTS WERE MALES AND 13 SUBJECTS WERE FEMALES. FIFTEEN PATIENTS HAD UNDERGONE SURGERY AND OBJECTIVE COMPLICATIONS OCCURRED IN 2 PATIENTS. HERE, ONLY 1 PATIENT REPORTED PAIN, SECOND DID NOT SUBJECTIVELY PERCEIVE MOVEMENT LIMITATION. SEVENTEEN PATIENTS WERE MANAGED CONSERVATIVELY AND TREATMENT INCLUDED A PHILADELPHIA COLLAR (4 SUBJECTS) OR A HALO APPARATUS (13 SUBJECTS). A COPY OF THE LITERATURE ARTICLE WILL BE SUBMITTED WITH THE MEDWATCH. THIS IS 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN DENS ACCESS DEVICE AND REFERS TO THE SERIOUS INJURY OF UNKNOWN PATIENTS WHO EXPERIENCED PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664362 TRAY, SURGICAL, INSTRUMENT FSM SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention