BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7650831 · Received June 29, 2018

    Report

    Report Number
    2210968-2018-73939
    Event Type
    Injury
    Date Received
    June 29, 2018
    Report Date
    June 5, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: INTERNATIONAL JOURNAL OF SURGERY 7 (2009) 510¿515; DOI:10.1016/J.IJSU.2009.08.013. [(B)(4).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: EXPERIENCE WITH CORTICAL TUNNEL FIXATION IN ENDOSCOPIC BROW LIFT: THE ¿¿BEVEL AND SLIDE¿¿ MODIFICATION". AUTHORS: CHARLES M. MALATA AND AHID ABOOD. CITATION: INTERNATIONAL JOURNAL OF SURGERY 7 (2009) 510¿515; DOI:10.1016/J.IJSU.2009.08.013. THIS PAPER PRESENTS A SINGLE SURGEON¿S EXPERIENCE WITH A TECHNICAL MODIFICATION TO MCKINNEY¿S ORIGINAL DESCRIPTION OF PARAMEDIAN CORTICAL TUNNEL FIXATION IN PATIENTS UNDERGOING ENDOSCOPIC BROW LIFTS. BETWEEN THE PERIOD OF JANUARY 2003 AND DECEMBER 2006, 30 PATIENTS (23 FEMALES, 7 MALES) WHO UNDERWENT A MODIFIED CORTICAL TUNNEL ENDOSCOPIC BROW LIFT FIXATION WERE INCLUDED IN THE STUDY. DURING THE PROCEDURE, PARAMEDIAN BROW FIXATION IS ACHIEVED USING 2/0 PROLENE SUTURES PASSED THROUGH THE PERIOSTEUM ANTERIOR TO THE PARAMEDIAN INCISION AND THEN ANCHORED IN CORTICAL BONE TUNNELS. THERE WERE TWO EARLY COMPLICATIONS. ONE PATIENT HAD A FIXATION SUTURE REMOVED UNDER LOCAL ANAESTHETIC 6 WEEKS POSTOPERATIVELY DUE TO ONGOING DYSAESTHESIA, LOCALISED TO THAT PARTICULAR SUTURE SITE. A SECOND DEVELOPED SIGNIFICANT INTERMITTENT FOREHEAD/SCALP DYSAESTHESIAE, WHICH WAS TREATED EXPECTANTLY AND RESOLVED EVENTUALLY. IN CONCLUSION, THIS SMALL BUT SINGLE OPERATOR SERIES ADDS WEIGHT TO LARGER STUDIES WHICH SHOW THAT THE PARAMEDIAN CORTICAL TUNNEL SUTURE FIXATION TECHNIQUE GIVES STABLE AND REPRODUCIBLE FIXATION OF BROW POSITION FOLLOWING ENDOSCOPIC BROW LIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492436 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention