MEDPOR IMPLANT 9959

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 2008-03-04 for MEDPOR IMPLANT 9959 manufactured by Porex Surgical.

Event Text Entries

[800913] The doctor stated that the patient received a medpor left and right mandible implant in 2007. At forty five days, the patient developed an infection in the area surrounding the left mandible implant. The doctor stated that he treated the area with antibiotic. The doctor reported that the infection did not resolve and four months later, he removed the left mandible implant.
Patient Sequence No: 1, Text Type: D, B5


[8042834] Following a review of the device history record for lot number 9959-159090702, it was determined that all processes and test criteria are within the medpor implant finished product spec.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1057129-2008-00004
MDR Report Key1007105
Report Source05
Date Received2008-03-04
Date of Report2008-02-20
Date of Event2007-12-06
Date Mfgr Received2008-02-11
Device Manufacturer Date2002-08-01
Date Added to Maude2008-03-11
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 FDA0
Event Location0
Manufacturer ContactKENT IVERSEN
Manufacturer Street15 DART ROAD
Manufacturer CityNEWNAN GA 30265
Manufacturer CountryUS
Manufacturer Postal30265
Manufacturer Phone6784791610
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDPOR IMPLANT
Generic NameFACIAL RECONSTRUCTION
Product CodeJAZ
Date Received2008-03-04
Model NumberNA
Catalog Number9959
Lot Number159090702
ID NumberNA
Device Expiration Date2012-08-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedV
Device Sequence No1
Device Event Key976837
ManufacturerPOREX SURGICAL
Manufacturer Address15 DART ROAD NEWNAN GA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-03-04

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