ALLOGRAFT *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-21 for ALLOGRAFT * manufactured by *.

Event Text Entries

[20883792] Pt admitted after mva underwent a posterolateral arthrodesis c4 to t3, segmental pedicle fixation, c4 to t3, posterolatral allograft c4 to t3 in 2004. Pt subsequently was diagnosed with fulminant liver failure during a 9/2004 admission and was diagnosed as hep b positive. Of the risk for hepatitis, the pt was an insulin dependent diabetic, surgery, transfusion and allograft. The pt received demineralized bone matrix grafts. Exp date 2005 and exp date 2006. Infection control coordinator reported.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 562055
• MDR Report Key: 562055
• Date Received: 2004-12-21
• Date of Event: 2004-05-20
• Date Facility Aware: 2004-12-15
• Report Date: 2004-12-16
• Date Reported to FDA: 2004-12-16
• Date Added to Maude: 2004-12-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: ALLOGRAFT
• Generic Name: ALLOGRAFT
• Product Code: LMO
• Date Received: 2004-12-21
• Model Number: *
• Catalog Number: *
• Lot Number: 005313751132
• ID Number: *
• Device Expiration Date: 2005-09-24
• Device Availability: *
• Device Age: NA
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 551770
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: ALLOGRAFT
• Generic Name: ALLOGRAFT
• Product Code: LMO
• Date Received: 2004-12-21
• Model Number: *
• Catalog Number: *
• Lot Number: 035343311177
• ID Number: *
• Device Expiration Date: 2006-03-11
• Implant Flag: Y
• Device Sequence No: 2
• Device Event Key: 572549
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2004-12-21