BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHILON NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 8586193 · Received May 7, 2019

    Report

    Report Number
    2210968-2019-81113
    Event Type
    Injury
    Date Received
    May 7, 2019
    Report Date
    April 10, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    NA
    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: INJURY INT. J. CARE INJURED. 2008; 39: 1198-1203. DOI: 10.1016/J.INJURY.2008.05.008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: "BRIDGING-MINIMALLY INVASIVE LOCKING PLATE OSTEOSYNTHESIS (BRIDGING-MILPO): TECHNIQUE DESCRIPTION WITH PROSPECTIVE SERIES OF 20 TIBIAL FRACTURES." AUTHORS: TIMOTHY H.D. WILLIAMS, WILLEM SCHENK. CITATION: INJURY INT. J. CARE INJURED. 2008; 39: 1198-1203. DOI: 10.1016/J.INJURY.2008.05.008. BRIDGING-MILPO PROVIDES AN ALTERNATIVE TO OTHER INTERNAL AND EXTERNAL DEVICES IN THE MANAGEMENT OF TIBIAL FRACTURES. THE AUTHORS DESCRIBED A REPRODUCIBLE TECHNIQUE OF BRIDGING-MINIMALLY INVASIVE LOCKING PLATE OSTEOSYNTHESIS (BRIDGING-MILPO) IN BOTH METAPHYSEAL AND DIAPHYSEAL FRACTURES OF THE TIBIA USING A STAINLESS STEEL LOCKING COMPRESSION PLATE (LCP) AND LOCKING SCREW. A TOTAL OF 20 CONSECUTIVE PATIENTS (14 MALE AND 6 FEMALE PATIENTS; AGE RANGE: 12 TO 85 YEARS OLD) WITH A UNILATERAL TIBIAL FRACTURE WERE TREATED USING BRIDGING-MILPO OVER A 31/2-YEAR PERIOD BETWEEN NOVEMBER 2003 AND JUNE 2007. DURING THE SURGICAL PROCEDURE, WOUND CLOSURE FOLLOWING SALINE WASH WAS PERFORMED WITH INTERRUPTED ETHILON (ETHICON) TO SKIN. REPORTED COMPLICATIONS INCLUDED CASE 2, A (B)(6) FEMALE PATIENT WITH MILD ANKLE PAIN, CASE 10, AN (B)(6) FEMALE PATIENT WITH WOUND INFECTION WHICH REQUIRED ORAL ANTIBIOTICS, CASE 14, A (B)(6) MALE PATIENT WITH WOUND INFECTION WHICH REQUIRED ORAL ANTIBIOTICS. THE HYPOTHESIZED PRINCIPLE OF RELATIVE STABILITY WAS ACHIEVED THROUGH A LOCKING PLATE. THESE SHOW THE PLATE IN SITU, BRIDGING THE FRACTURE WITH A RESULTANT LATERAL CALLUS FORMATION FROM THE PROPOSED MICRO-MOTION INDUCED BY IMMEDIATE FULL WEIGHT BEARING. BRIDGING-MILPO HAS PROVIDED A TYPICAL PATTERN OF FRACTURE UNION THROUGH CALLUS FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379915 ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention