BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOBLOCK IMPLANT, 10 MM

    MDR report key: 4101713 · Received August 28, 2014

    Report

    Report Number
    3004608878-2014-00151
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    October 21, 2011
    Report Date
    August 4, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HWC
    PMA / PMN Number
    K051611
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THIS IS THE FIRST REPORT OF TWO CONCERNING THE SAME PATIENT. THIS REPORT CONCERNS THE RIGHT FOOT. IT WAS REPORTED THAT THE PATIENT UNDERWENT BIOBLOCK IMPLANT SURGERY ON HIS RIGHT FOOT (B)(6) 2008. THE PT EXPERIENCED SHARP, SHOOTING PAINS IN HIS RIGHT FOOT THAT CAME AND WENT OVER THE COURSE OF SEVERAL MONTHS. HE WAS GIVEN INJECTIONS OF LIDOCAINE. ON (B)(6) 2011 HE RAN IN A RACE 'AND HIS RIGHT FOOT GAVE OUT' SUCH THAT HE WAS UNABLE TO PUT ANY WEIGHT ON IT AND SUFFERED IMMENSE PAIN. AN MRI OF THE RIGHT FOOT WHICH WAS TAKEN ON (B)(6) 2011, REVEALED THAT FRAGMENTS AND "LOOSE BODIES" REMAINED AND HAD NOT DISSOLVED. HE WAS GIVEN A BOOT FOR HIS FOOT AND CRUTCHES TO HELP HIM AMBULATE. ON (B)(6) 2011 HE UNDERWENT SURGERY ON HIS RIGHT FOOT FOR REMOVAL OF THE BROKEN DOWN PIECES OF IMPLANT AND EVACUATION OF INFLAMMATORY AND REACTIVE SOFT TISSUES WITHIN THE SINUS TARSI. ON (B)(6) 2012, THE PATIENT EXPERIENCED "REALLY BAD ANKLE PAIN" IN HIS RIGHT FOOT AND RATED THE PAIN AS 8 OUT OF 10. AN MRI REVEALED FOREIGN BODIES REMAINED IN THE FOOT IN SPITE OF THE PRIOR SURGERY SPECIFICALLY, THE MRI REPORT DATED (B)(6) 2012 NOTES "RETAINED FRAGMENT OF INTERFERENCE SCREW IN THE SINUS TARSI WITH ADDITIONAL SMALL FRAGMENTS LOCATED MORE SUPERFICIALLY." THE PT WAS REFERRED TO A SECOND SURGEON FOR FURTHER CONSULTATION AND TREATMENT. THE SECOND SURGEON PERFORMED SURGERY ON THE RIGHT FOOT ON (B)(6) 2012 TO REMOVE ADDITIONAL FRAGMENTS OF THE IMPLANT THAT DID NOT ABSORB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526491 BIOBLOCK IMPLANT, 10 MM BIOBLOCK HWC INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention