BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX

    MDR report key: 8817879 · Received July 23, 2019

    Report

    Report Number
    1221934-2019-57758
    Event Type
    Injury
    Date Received
    July 23, 2019
    Date of Event
    July 15, 2005
    Report Date
    July 5, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME, COMMON DEVICE NAME, PROCODE, MFR, LOT #, PART #, UDI #, 510K: THIS REPORT IS FOR AN UNKNOWN BIO-INTRAFIX. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). DEVICE EVALUATED BY MFR, MANUFACTURE DATE: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: CHRISTINE CRAWFORD ET AL, 2005, ¿INVESTIGATION OF POSTOPERATIVE ALLOGRAFT-ASSOCIATED INFECTIONS IN PATIENTS WHO UNDERWENT MUSCULOSKELETAL ALLOGRAFT IMPLANTATION¿, CLINICAL INFECTIOUS DISEASES 41 PAGE NO 195¿200, USA. THE STUDY EMPHASIZES ON DETERMINING THE EXTENT OF THE OUTBREAK AND IDENTIFYING RISK FACTORS OF POSTOPERATIVE ALLOGRAFT-ASSOCIATED INFECTIONS IN PATIENTS WHO UNDERWENT MUSCULOSKELETAL ALLOGRAFT IMPLANTATION. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: THIS IS A RETROSPECTIVE COHORT AND OBSERVATIONAL STUDY. TOTAL 331 PATIENTS WHO UNDERWENT ACL RECONSTRUCTIVE SURGERY DURING FEBRUARY 2000 THROUGH JUNE 2002, (202 WERE MALE; THE MEDIAN AGE WAS 35 YEARS (RANGE, 13¿64 YEARS)) WERE RECORDED FOR PATIENT DEMOGRAPHIC CHARACTERISTICS, SURGERY DETAILS, COMPLICATIONS (IF ANY), GRAFT AND DONOR DETAILS, SSI CHARACTERISTICS, PREVIOUS ARTHROSCOPIC PROCEDURES OR ACL RECONSTRUCTIVE SURGERY, AND TYPES OF FEMORAL OR TIBIAL FIXATION DEVICES USED IN PREVIOUS SURGICAL PROCEDURES. GRAFT DETAILS COLLECTED INCLUDED TYPE AND SIZE OF THE GRAFT AND WHETHER AN ALLOGRAFT OR AN AUTOGRAFT WAS INVOLVED. CAUSATIVE MICROORGANISM AND THE TIME FROM SPECIMEN COLLECTION TO POSITIVE CULTURE RESULT WERE ALSO DOCUMENTED. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ACL RECONSTRUCTIVE SURGICAL PROCEDURES BY USING SEVERAL METHODS OF FIXATION OF THE ALLOGRAFT TENDONS, AND TYPES OF DEVICES USED. THE DEVICES INVOLVED WERE: INTRAFIX WAS USED AS ONE OF THE TIBIAL FIXATION DEVICE IN 207 PATIENTS OUT OF 331. COMPLICATIONS MENTIONED IN THE ARTICLE WERE: 11 PATIENTS WERE ANALYZED OUT OF THAT 10 PATIENTS WERE REPORTED FOR SURGICAL SITE INFECTION OCCURRED AFTER TIBIAL FIXATION PROCEDURES. THE FIXATION DEVICE WAS REMOVED IN 8 OF THE 11 CASES. THIS IS REPORT ELEVEN OF ELEVEN FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609605 UNKNOWN BIO-INTRAFIX SOFT-TISSUE ANCHOR, BIOABSORBABLE HWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention