FDA.reportPublic FDA data

MAUDE MDR 9686779

MDR report key
9686779
Report number
MW5092870
Event key
0
Event type
3
Date of event
2020-02-05
Date received
2020-02-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ZYPPAH SNORING APPLIANCEDEVICE, ANTI-SNORINGZYPPAH, INC.LRKI Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0701. O

Event Narratives#

D

Patient 1

PERMANENTLY MISALIGNED JAW. I HAVE USED THE ZYPPAH SNORING APPLIANCE FOR SEVERAL YEARS. I HAVE RECENTLY BEEN DIAGNOSED (BY BOTH PROSTHODONTIST AND ORTHODONTIST) WITH A SERIOUS MISALIGNMENT OF JAW CAUSED BY EXTENDED USE OF THIS DEVICE. BOTH UPPER AND LOWER TEETH HAVE SHIFTED AND JAW HAS MOVE FORWARD. IT NOW REQUIRES EXTENSIVE ORTHODONTIA TO FIX TO PREVENT EVEN MORE EXTENSIVE DAMAGE TO MY TEETH LONG TERM DUE TO MISALIGNED BITE. HCPS REPORT THAT THIS IS A KNOWN ISSUE WITH THIS PRODUCT AND OTHERS LIKE IT, YET THERE ARE NO SAFETY WARNINGS TO PREVENT OTHER CONSUMERS FORM BEING SIMILARLY HARMED. FDA SAFETY REPORT ID # (B)(4).