VITALLIUM *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-01-07 for VITALLIUM * manufactured by Calcitek, Inc..

Event Text Entries

[120667] "failed dental, total, subperiosteal lower jaw implant with hydroxyapatite graft & etc... Calcitek. Alloy possibly vitallium corroded. Out in 15 months due to endocarditis. Collapsed pt lobe of lung. Mitral valve prolapse feb 14, 1989. 1990 surgical removal; systemic infection. Chest x-ray 1988 tells all. 1992 foreign body giant cell reaction; skin & eyes, severe eye uveitis which led to glaucoma. Yag laser surgery on pt eye to reduce pressures. Cannot remove all of the hydroxyopatite from bone. " x-ray taken at pain clinic at school of sentistry "showed hydroxyapatite to be vulnerable. 1995 several surgeries to "quiet nerve, bell's palsy type pain. Droopy pt face. 1998 sample of hydroxyapatite taken aug 1998. End result 1998 - need "cryoanalgesics" to quiet nerve pain. Dermatologist for facial giant cell reaction. Severe mandible (lower jaw) bone loss due to infection (corrosion).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1010526
• MDR Report Key: 60630
• Date Received: 1997-01-07
• Date of Event: 1988-01-01
• Date Added to Maude: 1997-01-08
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: VITALLIUM
• Generic Name: DENTAL ALLOY SUBPERIOSTEAL
• Product Code: ELE
• Date Received: 1997-01-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: N
• Implant Flag: Y
• Date Removed: Y
• Device Sequence No: 1
• Device Event Key: 61027
• Manufacturer: CALCITEK, INC.
• Manufacturer Address: 2320 FARADAY AVE CARLSBAD CA 920087216 US

Device Sequence Number: 2

• Brand Name: HYDROXYAPATITE GRAFT
• Generic Name: ENDOSSEOUS IMPLANT
• Product Code: DZE
• Date Received: 1998-08-31
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: *
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 180817
• Manufacturer: SULZER CALCITEK INC.
• Manufacturer Address: 2320 FARADAY AVE. CARLSBAD CA 92008 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening; 2. Deathisabilit	1997-01-07