BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7455785 · Received April 24, 2018

    Report

    Report Number
    2210968-2018-72321
    Event Type
    Injury
    Date Received
    April 24, 2018
    Report Date
    March 28, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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: PLAST RECONSTR SURG. 2003; 111(1): 27 38. DOI: 10.1097/01.PRS.0000036261.99248.09.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: RIGID FIXATION OF THE CALVARIA IN CRANIOSYNOTOSIS WITHOUT USING ¿RIGID¿ FIXATION AUTHORS: JEFFREY A. FEARON, MD, CITATION: PLAST RECONSTR SURG. 2003; 111(1): 27 38. DOI: 10.1097/01.PRS.0000036261.99248.09. THE PURPOSE OF THIS STUDY WAS TO REVIEW A SERIES OF INFANTS AND CHILDREN IN WHOM ABSORBABLE SUTURE FIXATION WAS USED AS THE SOLE METHOD OF FIXATION IN CRANIAL VAULT REMODELING. A TOTAL OF 137 PATIENTS WITH CRANIOSYNOSTOSIS UNDERWENT CRANIAL OSTEOTOMIES AND WERE CLOSED USING POLYDIOXANONE 2-0 SUTURES AND WERE INCLUDED IN THE STUDY. REPORTED COMPLICATION INCLUDED INFECTION (N-4). NO PATIENTS WERE NOTED TO HAVE UNEXPECTED OSSIFICATION DEFECTS. IT WAS REPORTED THAT THE AUTHOR¿S DECISION TO USE POLYDIOXANONE 2-0 SUTURE FOR SECURING REPOSITIONED SKULL SEGMENTS WAS BASED ON 2 FACTORS: THE SIMILARITY OF THIS SUTURE TO WIRE WITH RESPECT TO HANDLING AND THE COMPLETE RESORPTION OF POLYDIOXANONE WITHIN 3 TO 6 MONTHS. IT WAS CONCLUDED THAT THE USE OF ABSORBABLE SUTURE FIXATION WAS BOTH SAFE AND EFFICACIOUS. THE USE OF ABSORBABLE SUTURE MATERIAL DID NOT SEEM TO COMPROMISE THE AESTHETIC RESULT IN ANY WAY AND WAS ASSOCIATED WITH AN EXTREMELY LOW COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299219 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention