BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 24410853 · Received February 22, 2026

    Report

    Report Number
    1220246-2026-00798
    Event Type
    Injury
    Date Received
    February 22, 2026
    Date of Event
    April 1, 2011
    Report Date
    February 22, 2026
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    ON 23 JAN 2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED ON APRIL 2011 BY THE CLIN ORTHOP RELAT RES. ¿S THE ETIOLOGY OF PRETIBIAL CYST FORMATION AFTER ABSORBABLE INTERFERENCE SCREW USE RELATED TO A FOREIGN BODY REACTION?¿ THE STUDY REVIEWED 140 PATIENTS AND IDENTIFIED ACL/PCL INSTABILITY REQUIRING RESULTING IN A PRE-TIBIAL CYST WITH BIOABSORBABLE INTERFERENCE SCREWS IN 7 PATIENTS DURING THE 2-YEAR FOLLOW-UP PERIOD. REF: GONZALEZ-LOMAS G, CASSILLY RT, REMOTTI F, LEVINE WN. IS THE ETIOLOGY OF PRETIBIAL CYST FORMATION AFTER ABSORBABLE INTERFERENCE SCREW USE RELATED TO A FOREIGN BODY REACTION? CLIN ORTHOP RELAT RES. APR 2011;469(4):1082-8. DOI:10.1007/S11999-010-1580-5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471497 UNK SCREW, FIXATION, BONE HWC ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown