BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESH, SURGICAL

    MDR report key: 4353380 · Received December 22, 2014

    Report

    Report Number
    2520274-2014-15468
    Event Type
    Injury
    Date Received
    December 22, 2014
    Date of Event
    July 9, 2012
    Report Date
    December 3, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    FTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USE FOR TREATMENT NOT DIAGNOSIS. INTRAOPERATIVE CONE BEAM COMPUTED TOMOGRAPHY IN THE MANAGEMENT OF FACIAL FRACTURES. STUCK B.HULSE, R. BARTH T: INT. J. ORAL MAXILLOFAC. SURG. 2012; 41: 1171¿1175. THIS IS FOR A UNKNOWN TITANIUM IMPLANT (ORBITAL MESH) THAT WAS NOT PLACED IN THE OPTIMAL POSITION AND THE POSITION WAS CORRECTED. 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. 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 ARTICLEINTRAOPERATIVE CONE BEAM COMPUTED TOMOGRAPHY IN THE MANAGEMENT OF FACIAL FRACTURES. STUCK B. INT. J. ORAL MAXILLOFAC. SURG. 2012; 41: 1171¿1175. INTRAOPERATIVE CBCT (CONE BEAM COMPUTED TOMOGRAPHY) WAS FEASIBLE IN ALL 46 PATIENTS; 38 MEN AND 8 WOMEN AGED 19¿88 YEARS (MEAN 46 YEARS). IN 5 CASES, FRACTURE REDUCTION WAS INSUFFICIENT AND WAS OPTIMIZED FURTHER. IN 5 CASES, THE TITANIUM IMPLANT (ORBITAL MESH) WAS NOT PLACED IN THE OPTIMAL POSITION AND CORRECTED CONSECUTIVELY. DISPLACED BONY FRAGMENTS WERE DETECTED AND IMMEDIATELY REMOVED IN 2 CASES. IN 5 CASES, FRACTURE REDUCTION TURNED OUT TO BE INSUFFICIENT AND WAS FURTHER OPTIMIZED. CONCLUSION: INTRAOPERATIVE IMAGING PROVIDES A NUMBER OF POTENTIAL ADVANTAGES OVER POST-THERAPEUTIC IMAGING IN THE MANAGEMENT OF FACIAL FRACTURES. THIS REPORT IS FOUR OF FOUR FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN MATRIXNEURO MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841255 MESH, SURGICAL FTM SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention