PERFORMA

Description of Event or Problem

FROM A LETTER DATED 06/09/06 RECEIVED FROM AN ATTORNEY REPRESENTING THE PATIENT, IT IS CLAIMED THAT THE PATIENT "WAS ON TRACTION EQUIPMENT" AT A USER FACILITY IN 2004, WHEN THE DEVICE "MALFUNCTIONED, CAUSING SERIOUS INJURY TO BOTH OF [PATIENT]'S SHOULDERS." LETTER WAS SENT TO MANUFACTURER AND DISTRIBUTOR, BUT WITH NO ADDITIONAL INFORMATION REGARDING PATIENT CONDITION, USE CONDITIONS, OR OTHER RELEVANT DETAILS. IT IS YET UNKNOWN WHETHER CLAIMED INJURY WAS TEMPORARY OR IS PERMANENT.

Additional Manufacturer Narrative

DEVICE EVALUATION IS NOT POSSIBLE YET. INITIAL REPORT WAS RECEIVED FROM PATIENT'S ATTORNEY APPROXIMATELY TWO (2) YEARS AFTER THE CLAIMED ADVERSE EVENT. DISTRIBUTOR INITIALLY CONTACTED USER FACILITY, BUT WAS UNSUCCESSFUL IN EITHER CONFIRMING EVENT OR GATHERING FURTHER DETAILS REGARDING EVENT. U.S. AGENT FOR MANUFACTURER IS NOW DIRECTLY SEEKING ADDITIONAL INFORMATION FROM USER FACILITY REGARDING USE CONDITIONS, PATIENT OUTCOME, AND LOCATION/CONDITION/AVAILABILITY OF DEVICE FOR EVALUATION. REPORT UPDATE(S) SHALL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.