BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED BIO-EYE HA IMPLANT

    MDR report key: 2148883 · Received June 27, 2011

    Report

    Report Number
    2027377-2011-00001
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    May 7, 2009
    Report Date
    June 6, 2011
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS
    Product Code
    HPZ
    PMA / PMN Number
    K003338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPOSURE IS AN ANTICIPATED COMPLICATION OF ORBITAL IMPLANT SURGERY. IT IS GENERALLY TREATED CONSERVATIVELY AND IS SURGICALLY CLOSED IN ONLY IN THE CASE OF LARGE EXPOSURE OR IF THE WOUND DOES NOT SPONTANEOUSLY CLOSE WITHIN A REASONABLE TIME PERIOD. IN THIS INSTANCE THE WOUND REQUIRED SURGICAL CLOSURE. THE PT IS NOTED TO HAVE BEEN REPEATEDLY NONCONFORMANT WITH PHYSICIAN INSTRUCTIONS.

    Description of Event or Problem · 1

    EXPOSURE OF COATED BIO-EYE. PER THE COMPLAINANT: IMPLANTATION OF IOI IMPLANT PLACED (B)(6) 2008. AT POSTOP DAY #4 ((B)(6) 2008) IMPLANT INTACT, PLAN TO HAVE PT RETURN IN 2WKS... LOST TO FU (PT NO-SHOWED) PT RETURNED (B)(6) 2009 (2009) OVER 1 YEAR LATER: IMPLANT EXPOSED, 3 SUTURES PLACED WITHOUT COMPLICATION STARTED CIPRO DROPS, ASKED TO RETURN IN 1 MONTH (B)(6) 2009 IMPLANT NOTED TO EXPOSED AGAIN, 3 MORE SUTURES PLACED, STARTED ON BACITRACIN UNG (B)(6) 2009 4MM EXPOSURE NOTED PLANNED TO GO TO OPERATING ROOM FOR CLOSURE, LOST TO FU AGAIN (B)(6) 2010, PT SEEN BY OPTOMETRY, NOTED TO HAVE EXPOSURE, REFERRED TO OPHTHALMOLOGY (OUR CLINIC) ....PT DID NOT SHOW, ONCE AGAIN LOST TO F/U (B)(6) 2011 PT AGAIN NOTED TO HAVE EXPOSURE OF IMPLANT, WE PLANNED TO PERFORM SURGERY, PT SHOWED UP FOR PREADMISSION TESTING ON (B)(6) 2011 (PLANNED SURGERY ON (B)(6) 2011) AFTER TESTING WAS PERFORMED PT STATED HE WAS GOING TO DIVORCE COURT (B)(6) 2011 AND WOULD NOT BE ABLE TO BE HERE FOR HIS SURGERY. CURRENTLY WE ARE PLANNING ON RESCHEDULING SURGERY FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED BIO-EYE HA IMPLANT IMPLANT, EYE SPHERE, PRODUCT CODE: HPZ HPZ INTEGRATED ORBITAL IMPLANTS I0018C 36307

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention