BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9X23MM MILAGRO ADVANCE INTERFERENCE SCREW

    MDR report key: 6860504 · Received September 12, 2017

    Report

    Report Number
    1221934-2017-10509
    Event Type
    Injury
    Date Received
    September 12, 2017
    Report Date
    August 14, 2017
    Manufacturer
    DEPUY MITEK
    Product Code
    MAI
    PMA / PMN Number
    K123362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. INFORMATION PROVIDED IN THE EVENT INDICATES THAT ADDITIONAL INTERVENTION WAS DONE DUE TO CYST FORMATION AND PAIN TO THE PATIENT. ALTHOUGH CYST FORMATION IS AN EXPECTED OUTCOME FOR THIS MATERIAL OF THE IMPLANT, THIS REPORT IS BEING FILED DUE TO ADDITIONAL INTERVENTION TO THE PATIENT. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DHR REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED IN FUTURE, THIS FILE WILL BE RE-OPENED AND A THOROUGH INVESTIGATION WILL BE PERFORMED. DEPUY 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: (B)(4).

    Description of Event or Problem · 1

    MITEK DEPUY QUALITY DEPARTMENT RECEIVED AN EMAIL FROM DEPUY MARKETING STATING A SALES REP WAS QUESTIONING A CYSTIC FORMATION AFTER USING A MILAGRO ADVANCE ANCHOR. THE PATIENT HAD AN ACL RECONSTRUCTIVE SURGERY USING A SOFT TISSUE-ONLY QUAD TENDON GRAFT, ARTHREX RETRO ACL TIGHTROPE FOR FEMORAL FIXATION AND MILAGRO ADVANCE TIBIAL FIXATION. THEY SAID PATIENT IS TWO YEARS OUT AND HAD RECENTLY UNDERGONE AN MRI FOR KNEE PAIN. THE SURGEON IS FOLLOWING UP WITH THE PATIENT SOON AND HAD QUESTIONS REGARDING THE CYSTIC FORMATION. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE SALES REP ON 8-15-2017 DATE OF SURGERY ((B)(6) 2015). THE PATIENT RE-INJURED HERSELF ON ((B)(6) 2017). AND FOLLOWED UP AT THE HOSPITAL IN WHICH THE MRI WAS ORDERED FOR EXAM ON ((B)(6) 2017). THE PRODUCT USED WAS A 9X23 MILAGRO ADVANCE #231818.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638474 9X23MM MILAGRO ADVANCE INTERFERENCE SCREW MITEK ACL IMPLANTS MAI DEPUY MITEK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other