BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK RIGIDFIX CROSSPIN

    MDR report key: 5905276 · Received August 25, 2016

    Report

    Report Number
    1221934-2016-10366
    Event Type
    Injury
    Date Received
    August 25, 2016
    Report Date
    August 1, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK MEDICAL SAFETY DEPARTMENT REVIEWED 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 REMAINS 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. UDI: UNAVAILABLE. PRODUCT AND LOT INFO ARE NOT AVAILABLE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS FORWARDED TO MITEK PRODUCT COMPLAINTS FROM OUR MEDICAL SAFETY TEAM AFTER REVIEWING A JOURNAL ARTICLE FROM KNEE SURG SPORTS TRAUMATOL ARTHROSC (2008) 16:988-995 ON "ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING AUTOGRAFTS AND DOUBLE BIODEGRADABLE FEMORAL CROSS-PIN FIXATION: FUNCTIONAL, RADIOGRAPHIC AND MRI OUTCOME AFTER 2-YEAR MINIMUM FOLLOW-UP". IT WAS STATED IN THE 9 MONTH PERIOD BETWEEN DECEMBER 2003 AND AUGUST 2004, 56 PATIENTS UNDERWENT ACL RECONSTRUCTION USING DIFFERENT GRAFTS WITH THE RIGID FIX FEMORAL CROSS-PIN FIXATION. THE INTRA-ARTICULAR GRAFT WAS VISIBLE AND INTACT THROUGHOUT ALL PATIENTS, BUT ONE WHO REPORTED TRANSPLANT RE-RUPTURE AFTER A RECURRENT TRAUMA 3 MONTHS PRIOR TO FOLLOW-UP. AUTHORS: PATRICK WENINGER, BENNO ZIFKO, MICHAEL LISKA, RALF SPITALER, HARTMUT PELINKA, HARALD HERTZ. (B)(6). REFERENCE: TRAUMA HOSPITAL INSTITUTE FOR EXPERIMENTAL AND CLINICAL TRAUMATOLOGY DONAUESCHINGENSTRASSE 13, 1200 VIENNA, AUSTRIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557056 UNK RIGIDFIX CROSSPIN MITEK ACL IMPLANTS MAI DEPUY MITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other