BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7423126 · Received April 11, 2018

    Report

    Report Number
    2210968-2018-72092
    Event Type
    Injury
    Date Received
    April 11, 2018
    Report Date
    March 22, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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: TURK J MED SCI 2011; 41 (4): 639-646 DOI:10.3906/(B)(4) - [(B)(4) - OCGUDER 2011 (1).PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: COMPARISON OF THE OPEN PRIMARY REPAIR WITH AUGMENTATION AND WITHOUT AUGMENTATION IN ACUTE ACHILLES TENDON RUPTURE¿ AUTHOR(S): DURMUS ALI ÖÇGÜDER1, METIN DOGAN2, SÜLEYMAN BÜLENT BEKTASER1, ERKAN AKGÜN1, TOLGA TOLUNAY1, MAHMUT UGURLU CITATION: TURK J MED SCI 2011; 41 (4): 639-646 DOI:10.3906/(B)(4). THE STUDY AIMED TO COMPARE THE CLINICAL AND THE FUNCTIONAL EFFICIENCY OF 2 SURGICAL METHODS THAT ARE USED IN OPEN PRIMARY REPAIR OF ACUTE ACHILLES TENDON RUPTURES: ONE THAT UTILIZES THE AUGMENTATION OF THE PLANTARIS TENDON AND ONE THAT DOES NOT. BETWEEN FEB2003 AND MAY2007, 41 PATIENTS (N=38 MALE AND N=3 FEMALE; MEAN AGE OF 39 YEARS) WITH ACUTE ACHILLES TENDON RUPTURE UNDERWENT SURGICAL REPAIR WITH TWO DIFFERENT METHODS: GROUP 1 WHERE PATIENTS UNDERWENT AUGMENTATION WITH THE PLANTARIS TENDON AFTER AN END-TO-END PRIMARY REPAIR WITH A MODIFIED KESSLER TECHNIQUE (N=21) AND GROUP 2 WHERE AUGMENTATION WAS NOT PERFORMED. BOTH GROUPS UTILIZED 1 PDS SUTURES IN MODIFIED KESSLER METHOD. IN GROUP 1, VICRYL SIZE 4 WAS USED TO STITCH THE MEMBRANE AND RUPTURE. IN GROUP 2, PARTIAL RERUPTURE OCCURRED IN THE FOURTH MONTH OF TREATMENT ON ONE PATIENT AND WAS TREATED BY A CAST ORTHOSIS. WITH REGARD TO COMPLICATIONS, IN THE FIRST GROUP, 1 PATIENT (4.7%) DEVELOPED HYPERTROPHIC SCAR TISSUE. A SUPERFICIAL SKIN INFECTION WAS SEEN IN 2 (9.5%) PATIENTS FROM THE FIRST GROUP AND 3 (15%) PATIENTS FROM THE SECOND GROUP; ALL RECOVERED AFTER RECEIVING ANTIBIOTIC TREATMENT (CEFAZOLIN SODIUM). FINALLY, 1 (5%) PATIENT IN THE SECOND GROUP DEVELOPED A PARTIAL RERUPTURE IN THE FOURTH MONTH OF TREATMENT AND WAS TREATED BY A CAST ORTHOSIS. IN CONCLUSION, THE REPAIR INCLUDING AUGMENTATION IS A METHOD THAT SHOULD BE PREFERRED IN CASES OF CHRONIC, NEGLECTED, AND DEFECTIVE ACHILLES TENDON RUPTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266104 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention