FDA.reportPublic FDA data

MAUDE MDR 1508378

MDR report key
1508378
Report number
2027754-2009-00009
Event key
0
Event type
3
Date of event
2009-09-17
Date received
2009-10-09
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
3885 ARAPAHO RD. ADDISON TX 75001 US
Phone
972-972-9726
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1REFLEXION TOE SYSTEM1ST MPJ JOINTOSTEOMED L.P.LZJ370-0423370-04231021716R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-10-0901. R

Event Narratives#

D

Patient 1

PT IMPLANTED IN 2008. APPROX 4 WEEKS POSTOP, PT SHOWED SIGNS OF WARMTH OR REDNESS AROUND IMPLANT SITE. NO COMPLAINTS MADE TO COMPANY AT THAT TIME. ON 9/9/2009, THE REP WAS INFORMED THAT THE PT WAS TO BE RE-OPERATED. THE PT HAD BEEN PUT ON IV ANTIBIOTICS IN INTERVENING PERIOD, ALTHOUGH, ALL BLOOD CULTURES AND BONE BIOPSIES WERE NEGATIVE FOR INFECTION. DOCTOR INDICATED HE BELIEVES PT HAD AN ALLERGIC REACTION TO IMPLANT BECAUSE SHE "HAD SENSITIVITY TO CERTAIN TYPES OF EARRINGS" GOING BACK SEVERAL YEARS. THE IFU CAUTIONS AGAINST USE OF THE PRODUCT IN PTS WITH KNOWN METAL SENSITIVITIES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED IN THE LAST YEAR.

N

Patient 1

PRODUCT IS NOT EXPECTED TO BE RETURNED TO COMPANY. THIS INFO IS BASED ON VERBAL INTERVIEW OF SURGEON.