BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN SUSPENSORY FIXATION DEV

    MDR report key: 12465556 · Received September 13, 2021

    Report

    Report Number
    1219602-2021-01957
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    May 24, 2018
    Report Date
    November 17, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    GAT
    PMA / PMN Number
    K980155
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNAL COMPLAINT REFERENCE (B)(4). XU J, LIU H, LU W, LI D, ZHU W, OUYANG K, WU B, PENG L, WANG D. A RETROSPECTIVE COMPARATIVE STUDY OF ARTHROSCOPIC FIXATION IN ACUTE ROCKWOOD TYPE IV ACROMIOCLAVICULAR JOINT DISLOCATION: SINGLE VERSUS DOUBLE PAIRED ENDOBUTTON TECHNIQUE. BMC MUSCULOSKELET DISORD. 2018 MAY 24;19(1):170. DOI: 10.1186/S12891-018-2104-9. PMID: 29793464; PMCID: PMC5968503.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON LITERATURE REVIEW ¿A RETROSPECTIVE COMPARATIVE STUDY OF ARTHROSCOPIC FIXATION IN ACUTE ROCKWOOD TYPE IV ACROMIOCLAVICULAR JOINT DISLOCATION: SINGLE VERSUS DOUBLE PAIRED ENDOBUTTON TECHNIQUE¿; AFTER THE PROCEDURE USING ENDOBUTTON, ONE PATIENT HAD AN INFECTION. IT IS UNKNOWN HOW THIS WAS TREATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362988 UNKN SUSPENSORY FIXATION DEV SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT SMITH & NEPHEW, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O