MAUDE MDR 1293983

MDR report key
1293983
Report number
MW5009706
Event key
0
Event type
3
Date of event
2006-05-01
Date received
2009-01-21
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1RESPIRONICS, REMSTAR PLUSCPAP MACHINERESPIRONICS INC.NHJ1005960 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-01-2101. O

Event Narratives#

D

Patient 1

BEGAN USING A CPAP MACHINE FROM RESMED IN SUMMER OF 2005. IN LATE SPRING OF 2006, I NOTICED A SHIFTING OF 3 TEETH NO. 9, 10, 11. AFTER MANY X-RAYS, CT SCAN, ETC. IT WAS DETERMINED THAT I HAD A CYST AND SIGNIFICANT BONE LOSS IN THAT AREA. A 25 CM CYST WAS REMOVED IN 2006. I THEN HAS A ROOT CANAL OF TOOTH #10 AND WAS TOLD THAT WE WOULD MONITOR THE AREA FOR, HOPEFULLY, BONE GROWTH. ABOUT A YEAR LATER I, AGAIN, NOTICED TEETH MOVEMENT. AFTER ALL THE TESTS, ANOTHER CYST SMALLER, ABOUT 6-7 CM WAS REMOVED IN 2007. AND I HAD A ROOT CANAL ON TOOTH #9. AND, AGAIN WAS TOLD THAT WE WOULD CONTINUE TO MONITOR FOR BONE GROWTH. I NOTICED SHIFTING AGAIN LATE THIS SPRING. AT THIS TIME, I MENTIONED TO MY DENTIST AND ORAL SURGEON THE PROBLEMS THAT A FRIEND HAD AND WE BEGAN SPECULATING ABOUT WHETHER THE PRESSURE OF THE CPAP MASK WAS A CONTRIBUTING FACTOR TO MY PROBLEMS. THE CONSENSUS SEEMED TO BE YES. I STOPPED USING THE CPAP MACHINE AND JUST GOT A NEW NIGHT-GUARD/POSITIONING DEVICE. I WILL BE SEEING THE ORAL SURGEON YEARLY TO MONITOR THE SITUATION AND SEE IF THERE IS ANOTHER CYST OR IF THERE IS BONE GROWTH. THAT IS MY STORY IN A NUTSHELL. DATES OF USE: 2005--2008. DIAGNOSIS OR REASON FOR USE: SLEEP APNEA.