BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN - MAXON

    MDR report key: 12908126 · Received December 1, 2021

    Report

    Report Number
    9612501-2021-01978
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    May 25, 2021
    Report Date
    December 1, 2021
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: MINI-INVASIVE, ULTRASOUND GUIDED REPAIR OF THE ACHILLES TENDON RUPTURE-A PILOT STUDY SOURCE: J. CLIN. MED. 2021, 10, 2370 PUBLISHED: 28 MAY 2021 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED BETWEEN 2005 AND 2015, RE-RUPTURE OF THE TENDON IN TWO PATIENTS TWO MONTHS AFTER A PERCUTANEOUS ACHILLES TENDON REPAIR.  COMPLICATIONS WERE TREATED WITH OPEN PROCEDURE. IT WAS NOTED THAT BOTH PATIENTS HAD NOT FOLLOWED THE PHYSICAL THERAPY PROTOCOL. THE FIRST PATIENT WAS IMMOBILIZED FOR SIX WEEKS. THE SECOND PATIENT REMOVED THE BOOT AFTER FOUR WEEKS AND RECOMMENCED FULL WEIGHT-BEARING EXERCISES; THE RUPTURE OCCURRED DURING A DYNAMIC SPLIT SQUAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811993 UNKNOWN - MAXON SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD UNKNOWN - MAXON

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention