BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITEK ACL IMPLANTS

    MDR report key: 3760104 · Received April 18, 2014

    Report

    Report Number
    1221934-2014-00145
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    January 31, 2014
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK DISCOVERED THIS PUBLISHED WHITE PAPER DETAILING A HISTORICAL EVENT IN WHICH SOME MITEK DEVICES WERE IMPLICATED. IT CANNOT BE CONFIRMED THAT THIS ISSUE HAD BEEN PREVIOUSLY REPORTED TO MITEK, SO AN ADVERSE EVENT REPORT IS BEING FILED TO DOCUMENT THE EXPERIENCE DESCRIBED IN THE ARTICLE. AT THIS POINT IN TIME, NO FURTHER ACTION IS WARRANTED. HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FORTHCOMING INFORMATION RECEIVED THAT IS PERTINENT AND GERMANE TO THIS ISSUE. MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    AUTHOR: ANAKWENZE (2010) USA REFERENCE: ANAKWENZE OA, KANCHERLA V, KELLY JD 4TH. EXTRUSION OF TIBIAL TUNNEL BIOABSORBABLE SCREW 15 MONTHS AFTER ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION. ARTHROSCOPY. 2010 DEC;26(12):1710-3. E-MAIL: [email protected]. PATIENT CHARACTERISTICSB- AGE: (B)(6). GENDER: MALE. INDEX OPERATION: ACLR (ACHILLES TENDON WITH SINGLE-BONE BLOCK ALLOGRAFT), CHRONIC TEAR, REPAIR OF MENISCUS TEAR. DEVICES: METALLIC SCREW + BIO-INTRAFIX + RAPIDLOC. TIME OF COMPLICATION: 15 MO. TYPE OF COMPLICATION: PROTRUSION OF INTRAFIX SCREW. JOINT: KNEE. DEVICE: BIO-INTRAFIX. SUTURE: - NA. OTHER DEVICES: - NA. SIGNS AND SYMPTOMS: INCREASING RIGHT FOOT PAIN AND SWELLING, THEN RIGHT KNEE PAIN AT INCISION SITE, THEN DRAINAGE FROM THE TIBIAL INCISION. TISSUE DAMAGE: - NA. IMAGING STUDIES: - NA. REOPERATION (RELATED/UNRELATED): EXCISION OF SCREW WITH FORCEPS. MEDICAL TREATMENT: ANTIBIOTICS (BUT NO INFECTION.) F/U TIME: 1 WK. IMAGING STUDIES: - NA. OBJECTIVE OUTCOMES: WOUND HEALED, NO INFECTION. FUNCTIONAL OUTCOMES: - NA. SUBJECTIVE OUTCOMES: - NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237646 MITEK ACL IMPLANTS ACL IMPLANTS MAI DEPUY MITEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention