MEDPOR IMPLANT UNK

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 2005-07-15 for MEDPOR IMPLANT UNK manufactured by Porex Surgical, Inc..

Event Text Entries

[419015] The doctor stated that he had a patient with a temporal implant that was removed due to migration of the implant inot the bone. Patient's cndition after surgery was satisfactory.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1057129-2005-00028
• MDR Report Key: 621506
• Report Source: 05
• Date Received: 2005-07-15
• Date of Report: 2005-07-15
• Date of Event: 2005-06-13
• Date Mfgr Received: 2005-06-14
• Date Added to Maude: 2005-07-19
• 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: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: KENT IVERSEN
• Manufacturer Street: 15 DART ROAD
• Manufacturer City: NEWNAN GA 30265
• Manufacturer Country: US
• Manufacturer Postal: 30265
• Manufacturer Phone: 6784791610
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MEDPOR IMPLANT
• Generic Name: FACIAL RECONSTRUCTION
• Product Code: JAZ
• Date Received: 2005-07-15
• Model Number: NA
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: Y
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 611153
• Manufacturer: POREX SURGICAL, INC.
• Manufacturer Address: 15 DART RD. NEWNAN GA 30265 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-07-15