BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MILAGRO SCREW

    MDR report key: 8784790 · Received July 12, 2019

    Report

    Report Number
    1221934-2019-57620
    Event Type
    Injury
    Date Received
    July 12, 2019
    Report Date
    July 4, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN MILAGRO SCREW. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN BIO-INTRAFIX. (B)(4). 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. [(B)(4)].

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TRAVIS M. FALCONER ET AL 2016, ¿TUNNEL POSITIONING IN REMNANT SPARING DOUBLE BUNDLE ACL RECONSTRUCTION / A 2-YEAR STUDY OF MRI TUNNEL POSITIONS, CLINICAL OUTCOMES AND TUNNEL CONFLUENCE¿, JOURNAL OF MUSCULOSKELETAL RESEARCH, VOL. 19, NO. 1, 15 PAGES, DOI: 10.1142/S0218957716500044, AUSTRALIA. THE STUDY EMPHASIZES ON THE EXAMINATION ON THE OUTCOMES OF A COHORT OF PATIENTS WHO HAVE UNDERGONE A NEW SURGICAL TECHNIQUE FOR ANTERIOR CRUCIATE LIGAMENT (ACL) TUNNEL TARGETING USING THE FOOTPRINT OF THE TORN ACL AS SOFT TISSUE MARKERS. THIS IS IN THE SETTING OF ANATOMICAL ACLR WITH REMNANT PRESERVATION. THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: A TOTAL OF 103 PATIENTS UNDERWENT ACLR WITH A REMNANT SPARING TECHNIQUE WITH NON-RADIOLOGICAL SOFT TISSUE TARGETING OF FEMORAL AND TIBIAL TUNNELS. A TOTAL OF 44 PATIENTS (18 MALES, 26 FEMALES; MEAN AGE 30.9 YEARS +/- 11.8) WERE ENROLLED WITHIN THE STUDY. A TOTAL OF 20 OF THE RECONSTRUCTIONS WERE OF THE LEFT KNEE AND 24 OF THE RIGHT KNEE. THE MEAN OPERATING TIME, AS RECORDED BY VIDEO ARTHROSCOPY WAS 45 MIN (Þ/_12). ALL PATIENTS HAD A MINIMUM OF 2 YEARS FOLLOW UP (2¿3.9 YEARS). THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: DOUBLE TUNNEL ANATOMICAL RECONSTRUCTION WITH ACL REMNANT PRESERVATION. THIS TECHNIQUE USES THE FOOTPRINT OF THE TORN ACL AND ITS REMNANT AS SOFT TISSUE MARKERS FOR TUNNEL PLACEMENT. THE DEVICES INVOLVED WERE: THE AMB WAS FIXED AT 45_ OF FLEXION INTRAFIX SCREW AND THE PLB WAS FIXED AT 20 OF FLEXION MILAGRO ADVANCE SCREW. COMPLICATIONS MENTIONED IN THE ARTICLE WERE: THERE WERE 2 MRI CYCLOPS LESIONS IDENTIFIED AT THE 1-YEAR SCAN AND ONLY ONE OF THESE REMAINED PRESENT AT THE 2-YEAR SCAN. ONE PATIENT HAD SOME MILD SYMPTOMS OF INSTABILITY WITH A POSITIVE PIVOT SHIFT AND A KT-1000 DIFFERENCE OF 5 MM. TWO PATIENTS RETURNED TO THEATER. ONE WAS FOR A MENISCAL TEAR 12 MONTHS AFTER THEIR RECONSTRUCTION. THE OTHER PATIENT HAD SYMPTOMS OF GRAFT IMPINGEMENT AND REQUIRED AN ARTHROSCOPIC NOTCHPLASTY 4 MONTHS POST-ACL RECONSTRUCTION. EXCLUSION CRITERIA CONCOMITANT MENISCAL REPAIR OR LIGAMENT SURGERY, KNEE MALALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577415 UNKNOWN MILAGRO SCREW ORTHOPAEDIC BONE SCREW, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention