BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9193502 · Received October 15, 2019

    Report

    Report Number
    2210968-2019-88512
    Event Type
    Injury
    Date Received
    October 15, 2019
    Report Date
    September 17, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: INT. J. ORAL MAXILLOFAC. SURG. (2011); 40: 907¿915. DOI:10.1016/J.IJOM.2011.05.001 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE "TITLE: IMMEDIATE FUNCTIONAL LOADING OF PROVISIONAL IMPLANTS IN THE RECONSTRUCTED ATROPHIC MAXILLA: PRELIMINARY RESULTS OF A PROSPECTIVE STUDY AFTER 6 MONTHS OF LOADING WITH A PROVISIONAL BRIDGE". AUTHORS: O. LENSSEN1, L. BARBIER2, C. DE CLERCQ. CITATION: INT. J. ORAL MAXILLOFAC. SURG. (2011); 40: 907¿915. DOI:10.1016/J.IJOM.2011.05.001. THE PURPOSE OF THIS PROSPECTIVE PILOT STUDY IS TO PRESENT THE PRELIMINARY RESULTS AFTER IMMEDIATE FUNCTIONAL LOADING OF PROVISIONAL IMPLANTS IN THE RECONSTRUCTED ATROPHIC MAXILLA. A PROSPECTIVE PILOT STUDY WAS CARRIED OUT IN 10 PATIENTS (1 MALE AND 9 FEMALE; AVERAGE AGE: 52 YEARS; AGE RANGE: 39-60 YEARS) WHO UNDERWENT BONY RECONSTRUCTION OF ATROPHIC MAXILLAE UNDER GENERAL ANAESTHESIA, WITH AUTOLOGOUS CALVARIAL BONE GRAFTS AND SIMULTANEOUS PLACEMENT OF SIX PROVISIONAL IMPLANTS FROM 2006 TO 2009. AFTER THE PLACEMENT OF THE IMMEDIATE PROVISIONAL IMPLANTS (IPIS), THE PERIOSTEUM WAS RELEASED TO OBTAIN A TENSIONLESS CLOSURE. SUBSEQUENT TO ROUNDING THE SHARP EDGES, SURPLUS BONE PLATES WERE GROUND IN A BONE MILL AND THE GROUND BONE PASTE PRODUCED WAS ADDED TO COVER THE ONLAYS. THE MUCOPERIOSTEUM WAS CLOSED TENSION-FREE WITH VICRYL 3/0 RESORBABLE BRAIDED SUTURES (ETHICON). REPORTED COMPLICATIONS INCLUDED PERI IMPLANT INFECTION SURROUNDING ALL IPIS, WITH LOCAL BONE LOSS (N-1). IN CONCLUSION, THE PRELIMINARY RESULTS OF THIS (B)(4) STUDY DEMONSTRATE THAT THIS TREATMENT PROTOCOL IS A WELL TOLERATED TREATMENT FOR PATIENTS WITH MAXILLARY ATROPHY DESIRING DENTAL REHABILITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988944 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention