BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN POLYSORB SUTURE

    MDR report key: 21000782 · Received December 23, 2024

    Report

    Report Number
    9612501-2024-03145
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    October 16, 2023
    Report Date
    December 23, 2024
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MID-TERM OUTCOMES OF ARTHROSCOPICALLY ASSISTED LOWER TRAPEZIUS TENDON TRANSFER USING ACHILLES ALLOGRAFT IN TREATMENT OF POSTERIOR-SUPERIOR IRREPARABLE ROTATOR CUFF TEAR. / CHANG HEE BAEK, MD, BO TAEK KIM, MD, JUNG GON KIM, MD, SEUNG JIN KIM, MS / J SHOULDER ELBOW SURG (2024) 33, 1293-1305 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE SOURCE OF THE STUDY PERFORMED ON PATIENTS WHO UNDERWENT (ALTT) ARTHROSCOPICALLY ASSISTED LOWER TRAPEZIUS TENDON TRANSFER IN PATIENTS WITH POSTERIOR-SUPERIOR IRREPARABLE ROTATOR CUFF TEAR OVER A MID-TERM DURATION BETWEEN MAY 2017 AND MAY 2019. INFECTIONS DEVELOPED IN 2 PATIENTS (5.6%), WHO SUBSEQUENTLY UNDERWENT ARTHROSCOPIC DEBRIDEMENT, IRRIGATION, AND ANTIBIOTIC TREATMENT. THE INTERVAL FROM THE INDEX SURGICAL PROCEDURE TO THE DIAGNOSIS OF INFECTION WAS APPROXIMATELY 6 WEEKS. THE INFECTION WAS LIMITED TO THE INTRA-ARTICULAR SPACE, AND THERE WAS NO INVOLVEMENT OF THE ALLOGRAFT TO THE LOWER TRAPEZIUS INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65701 UNKNOWN POLYSORB SUTURE SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD UNKNOWN POLYSORB SUTURE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R