FDA.reportPublic FDA data

MAUDE MDR 2115161

MDR report key
2115161
Report number
3005344923-2011-00001
Event key
0
Event type
3
Date of event
2011-04-08
Date received
2011-05-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
950 LEE STREET SUITE 210 DES PLAINES IL 60016 US
Phone
847-847-8472
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALPHASPHERE ORBITAL IMPLANT886.3320 - HPZADDITION TECHNOLOGYHPZAS-22AS-134-10BR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-05-2601. R

Event Narratives#

D

Patient 1

PT PRESENTED FOR F/U ONE MONTH SUBSEQUENT TO THE INSERTION OF AN ORBITAL IMPLANT. THE ORBITAL IMPLANT WAS INSERTED AFTER ENUCLEATION OF THE EYE FOR CHOROIDAL MELANOMA. THE PT WAS FOUND TO HAVE CONJUNCTIVAL DEHISCENCE OVER THE IMPLANT. THE PT WAS INITIALLY RETURNED TO THE OPERATING ROOM FOR CONJUNCTIVAL REPAIR INSTEAD OF IMPLANT EXCHANGE. THE WOUND WAS EXPLORED. THE MESH CONNECTING THE TWO HEMISPHERES OF THE DEVICE WAS FOUND TO BE VERY FRIABLE AND THE MUSCLES WERE NO LONGER ATTACHED TO THE IMPLANT DESPITE ATTEMPTS MADE DURING THE PRIMARY PROCEDURE TO ENSURE SUTURING TO THE MESH. THE CAPSULE AROUND THE IMPLANT WAS SUBMITTED FOR PATHOLOGY AND REVEALED FOREIGN BODY GIANT CELL REACTION.

N

Patient 1

IT IS UNCLEAR WHY THIS UNIT WAS REJECTED BY THE PT. TYPICALLY, ALPHASPHERE UNITS BIOINTEGRATE WITH THE PT'S MUSCLES WITHOUT ISSUE. THIS IS THE FIRST COMPLAINT OF THIS TYPE AND SINCE THERE IS ONLY ONE DATA POINT AND NO UNIT TO EXAMINE, NO CONCLUSIONS CAN RELIABLE BE DRAWN.