TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM FEL-KIT (17)& LCP-KIT (001-50)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-03-03 for TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM FEL-KIT (17)& LCP-KIT (001-50) manufactured by Tmj Implants, Inc..

Event Text Entries

[18328140] Surgeon stated the device was explanted due to persistent pain. The pathology report states left fossa, debridement-foreign body granulation in fibrocartilage.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1721760-1999-00005
• MDR Report Key: 212887
• Report Source: 05
• Date Received: 1999-03-03
• Date of Report: 1999-02-08
• Date of Event: 1999-01-27
• Report Date: 1999-02-08
• Date Reported to Mfgr: 1999-02-08
• Date Mfgr Received: 1999-02-08
• Device Manufacturer Date: 1992-05-01
• Date Added to Maude: 1999-03-09
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM
• Generic Name: LEFT FOSSA-EMINENCE & CONDYLAR PROSTHESIS
• Product Code: JAZ
• Date Received: 1999-03-03
• Returned To Mfg: 1999-02-02
• Model Number: NA
• Catalog Number: FEL-KIT (17)& LCP-KIT (001-50)
• Lot Number: (FEL)2-0015 & (LCP)2-0067
• ID Number: NA
• Operator: LAY USER/PATIENT
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 206562
• Manufacturer: TMJ IMPLANTS, INC.
• Manufacturer Address: 17301 WEST COLFAX AVE., SUITE 135 GOLDEN CO 804014800 US
• Baseline Brand Name: TMJ FOSSA-EMINENCE & CONDYLAR PROSTHESIS SYSTEM
• Baseline Generic Name: LEFT FOSSA-EMINENCE & CONDYLAR PROSTHESIS
• Baseline Model No: NA
• Baseline Catalog No: FEL-KIT (17)& LCP-KIT (001-50)
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-03-03