FDA Adverse Event Malfunction Summary report: N

OSTEOVATION IMPACT 5CC AND INJECT 5CC

MDR report key: 1557146 · Received November 25, 2009

Report

Report Number: 3003890476-2009-00002
Event Type: Malfunction
Date Received: November 25, 2009
Date of Event: May 13, 2008
Report Date: November 25, 2009
Manufacturer: SKELETAL KINETICS, LLC
Product Code: GXP
PMA / PMN Number: K051784
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

ADD'L CATALOG #: 390-2105. ADD'L LOT #: 7071906. ADD'L EXPIRATION DATE: 05/31/2008. ADDITIONAL DEVICE MANUFACTURE DATE: 08/2007. THE SAME LOTS OF THE ACTUAL DEVICES INVOLVED IN INCIDENT WERE EVALUATED, AND THE RESULTS SHOWED BOTH LOTS TO BE STABLE OVER TIME AND MET LOT RELEASE CRITERIA. OSTEOVATION SHOULD NOT BE USED WITH K WIRES, THE DRILL USED MUST BE THREADED AND FLUTED TO PREVENT THE BREAKDOWN OF THE CEMENT, HOWEVER THE DOCTOR USED GUIDEWIRE/K WIRE THROUGH THE CEMENT WHICH WAS AN OFF-LABEL USE.

Description of Event or Problem · 1

ON (B)(6) 2008, "REVISION OF A HAMMERTOE" AND REMOVAL OF COMPETITOR'S CEMENT WAS PERFORMED BY USING OSTEOVATION INJECT 5CC, CATALOG # 390-2005, LOT # 08011804, IT DID NOT PROPERLY SET-UP IN THE ALLOTTED TIME FRAME AND ENDED UP WASHING OUT OF THE WOUND SIGHT. THE SECOND BATCH USED WAS OSTEOVATION IMPACT 5CC, CATALOG # 390-2105, LOT # 7071906, THAT ALSO DID NOT SET-UP THAT GREAT, HOWEVER, IT DID HARDEN. THE DOCTOR WASN'T HAPPY WITH THE WAY IT WAS HOLDING AND TRIED TO PLACE A GUIDE WIRE THROUGH THE CEMENT AND IT COMPLETELY BROKE THE CEMENT DOWN INTO LITTLE PIECES. THE ONLY OTHER OPTION AFTER THAT, WAS TO GET PERMISSION FROM THE PATIENT'S FAMILY TO HARVEST A BONE GRAFT FROM HER ANKLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OSTEOVATION IMPACT 5CC AND INJECT 5CC	21 CFR 882.5300 GXP	GXP	SKELETAL KINETICS, LLC		08011804

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			GUIDE WIRE