FDA.reportPublic FDA data

MAUDE MDR 1491277

MDR report key
1491277
Report number
1057129-2009-00010
Event key
0
Event type
3
Date of event
2009-03-09
Date received
2009-10-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KENT IVERSEN
Address
15 DART RD. NEWNAN GA 30265 US
Phone
678-678-6784
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDPOR IMPLANTFACIAL RECONSTRUCTIONPOREX SURGICALEPPNA84012C417K12R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-10-0101. O

Event Narratives#

D

Patient 1

THE DOCTOR REPORTED TO A DISTRIBUTOR THAT THE PATIENT RECEIVED A MEDPOR NASAL IMPLANT IN 2009. THE DOCTOR STATED THAT THE SURGERY WAS FOR RECONSTRUCTION OF THE NASAL SEPTUM. THE DOCTOR STATED THAT THE IMPLANT WAS CUT TO SHAPE AND IMPLANTED. THE DOCTOR STATED THAT "THE INTERVENTION" WAS A LOT LESS EXTENSIVE THANKS TO THE IMPLANT SO THAT THE PLANNED HOSPITALIZATION IS NOT NECESSARY". THE DOCTOR STATED THAT HE WOULD REMOVE THE SUTURE IN ONE WEEK AND DUE TO THE SMALL INCISION, IMPLANT SECURING IS A LOT MORE PROBABLE. THE DOCTOR STATED THAT IN 2009, A FOREIGN BODY REACTION IN THE NASAL DORSUM AREA OCCURRED. THE DOCTOR STATED THAT THE IMPLANT EXTRUDED THROUGH THE SKIN. THE DOCTOR REPORTED THAT HE REMOVED THE MEDPOR NASAL IMPLANT AND PLACED A POLYETHYLENE PLACEHOLDER. THE DOCTOR STATED THAT THE PATIENT IS SATISFIED WITH THE RESULTS.

N

Patient 1

FOLLOWING A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 84012-C417K12, IT WAS DETERMINED THAT ALL PROCESSES AND TEST CRITERIA ARE WITHIN THE MEDPOR IMPLANT FINISHED PRODUCT SPECIFICATION.