UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-28 for UNK * manufactured by Unk.

Event Text Entries

[139394] Pt reported jaw implant placed by "unknown" dentist approx 10 years ago. Causative for osteomyelitis type infection of the left mandible warranting implant removal with bone graft repair.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 302485
• MDR Report Key: 302485
• Date Received: 2000-10-28
• Date of Report: 2000-10-26
• Date of Event: 2000-09-01
• Date Facility Aware: 2000-10-25
• Report Date: 2000-10-26
• Date Reported to FDA: 2000-10-26
• Date Added to Maude: 2000-11-02
• 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: 0
• Reporter Occupation: RISK MANAGER
• 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 Details

• Brand Name: UNK
• Generic Name: MANDIBLE IMPLANT
• Product Code: JAZ
• Date Received: 2000-10-28
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: SIZE: 1.6 X 0.4 X 0.4 CM
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 10 YR
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 292771
• Manufacturer: UNK
• Manufacturer Address: UNK UNK *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2000-10-28