FDA.reportPublic FDA data

MAUDE MDR 1445403

MDR report key
1445403
Report number
MW5012490
Event key
0
Event type
3
Date of event
2009-08-03
Date received
2009-08-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTRATINE FOREHEAD BIOSORBABLE IMPLANTULTRATINE 3.0COAPT SYSTEMSNDL2320002092

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-08-2001. R

Event Narratives#

D

Patient 1

NINE MONTHS AGO, THE PT HAD ENDOSCOPIC FOREHEAD LIFT WITH IMPLANTATION OF BILATERAL ULTRATINES TO SECURE THE LIFTED FOREHEAD POSITION. IN THE MONTHS FOLLOWING SURGERY, THE PT DEVELOPED AN INFLAMED, CYSTIC MASS OVER THE ULTRATINES, WHICH SLOWLY ENLARGED, FINALLY REQUIRING ADDITIONAL SURGERY TO REMOVE. AT SURGERY, AN INFLAMED CYSTIC CAVITY FILLED WITH REMNANTS OF THE ULTRATINE AND WHAT APPEARED TO BE GRANULOMATOUS INFLAMMATION WAS OBSERVED. ALL MATERIAL WAS REMOVED. THERE WAS THINNING OF THE CORTICAL BONE UNDERLYING THE IMPLANT, AND THE ANCHOR HOLE FOR THE ULTRATINE WAS ENLARGED. THERE WAS NO PENETRATION THROUGH THE POSTERIOR CORTICAL BONE.