BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI QA+ W/ #2/0 OCORD AND V-5 NEEDLE W/BIT

    MDR report key: 6128162 · Received November 27, 2016

    Report

    Report Number
    1221934-2016-10507
    Event Type
    Injury
    Date Received
    November 27, 2016
    Date of Event
    May 5, 2015
    Report Date
    October 28, 2016
    Manufacturer
    DEPUY MITEK
    Product Code
    JDR
    PMA / PMN Number
    K071257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DEVICE IS NOT AVAILABLE FOR A PHYSICAL EVALUATION. NO FURTHER INFORMATION REGARDING THE TECHNIQUE OR INSTRUMENTS USED HAS BEEN PROVIDED TO DETERMINE A ROOT CAUSE FOR THIS FAILURE. PATIENT'S CURRENT CONDITION IS UNKNOWN. FURTHERMORE, NO LOT NUMBERS WERE SUPPLIED WHICH PRECLUDES CONDUCTING A DHR REVIEW OR A LOT SPECIFIC SEARCH IN THE COMPLAINTS HANDLING SYSTEM. A REVIEW OF THIS PRODUCT CODE REVEALED NO OTHER SIMILAR COMPLAINTS IN THE LAST 3 YEARS. AT THIS POINT IN TIME, 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4). DEPUY SYNTHES HAS BEEN INFORMED THAT THE LOT NUMBER IS NOT AVAILABLE.

    Description of Event or Problem · 1

    PATIENT HAS ALLERGIC REACTION DUE TO IMPLANTED ANCHOR, THE IMMUNE SYSTEM REACTS SENSITIVE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON 11-1-16. THE RIGHT DESCRIPTION IS: GII MINI QUICK ANCHOR PLUS ((B)(4)). WHAT TYPE OF PROCEDURE DID THE PATIENT HAVE ON (B)(6) 2015? RIGHT FOOT OPERATION: EP ARTHRODESE D1, EHL-EHB TRANSFER, EDL-EDB TRANSFER 2-5, EDLELONGATION 5, HOHMANN OP 2-4, DISTALE FLEXORTENOTOMIE 2-4. IT IS UNKNOWN WHEN THE ISSUE STARTED. THE PATIENT¿S SYMPTOMS WAS LITTLE REDNESS AROUND THE SCAR. LOT NUMBER IS UNKNOWN. AN ALLERGIC REACTION TEST HAS BEEN DONE, THE RESULTS OFT HE TESTS ARE NOT HERE YET. THE ANCHOR IS NOT GOING TO BE REMOVED AS OF NOW. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778906 MINI QA+ W/ #2/0 OCORD AND V-5 NEEDLE W/BIT MITEK ANCHOR IMPLANTS JDR DEPUY MITEK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other