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 2008-03-20 for MEDPOR IMPLANT UNK manufactured by Porex Surgical.

Event Text Entries

[810372] The doctor stated that the patient received a medpor implant in the right maxilla area in 2006. The doctor reported that the area became infected and he removed the implant in the same year.
Patient Sequence No: 1, Text Type: D, B5

[8050626] Lot number information was not provided, therefore, a review of the device history records could not be performed.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1057129-2008-00011
• MDR Report Key: 1017128
• Report Source: 05
• Date Received: 2008-03-20
• Date of Report: 2008-03-14
• Date of Event: 2006-03-08
• Date Mfgr Received: 2008-02-12
• Date Added to Maude: 2009-12-30
• 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: 0
• 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
• 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: JOF
• Date Received: 2008-03-20
• Model Number: NA
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: DA
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: POREX SURGICAL
• Manufacturer Address: 15 DART ROAD NEWNAN GA US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2008-03-20