FDA Adverse Event Other Summary report: N

CALLOS INJECT PLUS AND IMPACT PLUS

MDR report key: 824222 · Received February 23, 2007

Report

Report Number: 3003890476-2007-00001
Event Type: Other
Date Received: February 23, 2007
Date of Event: January 2, 2007
Report Date: January 26, 2007
Manufacturer: SKELETAL KINETICS, LLC
Product Code: GXP
PMA / PMN Number: k051123
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KS
Reporter Occupation: INVALID DATA

Narratives

Additional Manufacturer Narrative · 1

BASED ON THE INITIAL REPORT, IT IS UNCLEAR HOW THE DEVICE WAS USED IN THE REPORTED EVENT. SINCE THE ACTUAL DEVICE LOT NUMBER INVOLVED IN THE REPORTED EVENT IS UNK, ALL LOTS SHIPPED TO ANOTHER COUNTRY, WITHIN THE INITIAL BUILD TO THE EXPIRATION DATE THAT MIGHT HAVE BEEN USED WERE EVALUATED AT SKELETAL KINETICS. IT WAS FOUND THAT ALL FUNCTIONAL TESTING PROCEDURES WERE FOLLOWED AND MET THE SPECIFICATIONS.

Description of Event or Problem · 1

ON 1/26/2007 IT WAS REPORTED TO SKELETAL KINETICS THAT CALLOS WAS USED IN A KYPHOPLASTY PROCEDURE IN ANOTHER COUNTRY, TO TREAT A PATIENT PRESENTING WITH A COLLAPSED VERTEBRATE. ACCORDING TO THE INITIAL REPORT IT APPEARS THE TREATED VERTEBRATE WAS NOT FULLY STABILIZED RESULING IN A FURTHER COLLAPSE OF THE SITE AND DISLODGEMENT OF CALLOS POST TREATMENT. AS A RESULT, THE PATIENT IS CURRENTLY BEING HOSPITALIZED FOR CONTINUAL PAIN. BASED ON THE INITIAL REPORT, REVIEW OF X-RAYS AND SUBSEQUENT CONVERSATIONS WITH REPRESENTATIVE IN ANOTHER COUNTRY, SKELETAL KINETICS IS UNABLE TO DETERMINE IF CALLOS MAY HAVE CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. CURRENTLY CALLOS IS NOT APPROVED FOR USE NOR IS IT MARKETED FOR KYPHOPLASTY IN THE UNITED STATES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CALLOS INJECT PLUS AND IMPACT PLUS	BONE VOID FILLER	GXP	SKELETAL KINETICS, LLC	CALLOS INJECT PLUS	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	70 YR		Hospitalization\| R