MEDPOR IMPLANT 9865

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 2005-07-14 for MEDPOR IMPLANT 9865 manufactured by Porex Surgical.

Event Text Entries

[427539] The doctor stated that he had a patient with severe head and neck cancer who was given a short period to live. He placed a pterional implant that became exposed and developed an infection. The doctor stated that there was not anything wrong with the implant but that the patient had an exposed track to their mouth which could have caused the infection.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1057129-2005-00026
MDR Report Key621445
Report Source05
Date Received2005-07-14
Date of Report2005-07-14
Date of Event2005-06-14
Date Mfgr Received2005-06-14
Date Added to Maude2005-07-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer Street15 DART ROAD
Manufacturer CityNEWNAN GA 30265
Manufacturer CountryUS
Manufacturer Postal30265
Manufacturer Phone6784791610
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDPOR IMPLANT
Generic NameFACIAL RECONSTRUCTION
Product CodeJAZ
Date Received2005-07-14
Model NumberNA
Catalog Number9865
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key611093
ManufacturerPOREX SURGICAL
Manufacturer Address15 DART RD. NEWNAN GA * US
Baseline Brand NameMEDPOR IMPLANT
Baseline Generic NameFACIAL RECONSTRUCTION
Baseline Model NoNA
Baseline Catalog No9865
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2005-07-14

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