FDA.reportPublic FDA data

MAUDE MDR 3300130

MDR report key
3300130
Report number
1925223-2013-00099
Event key
0
Event type
3
Date received
2013-08-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
4315 SOUTH LAFAYETTE BLVD. SOUTH BEND IN 46614 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MONDIAL 6HERAEUS KULZER GMBHELMA1 R45566016845 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-08-130

Event Narratives#

D

Patient 1

THIS IS THE FIRST OF THIRTEEN DEVICE REPORTS FROM ONE DENTAL LAB. A DENTAL LAB NOTIFIED LOCAL HK REP OF MONDIAL TEETH THEY WANT TO REPLACE DUE TO SHEARING. THE LAB DID NOT GIVE INDIVIDUAL INFO ON PTS AND DATES. THE HK REP EXPLAINED THAT THIS HAPPENS WITH THE ALL-ON 4'S AND THE FACT THAT THE TEETH SHEAR BEFORE THE IMPLANT DOES IS A GOOD THING. ON (B)(6) 2013, CONTACTED THE DENTURE SET UP GUYS FROM THE LAB. THEY SAID THE TEETH SHEARED WHILE IN THE PT'S MOUTH. THEY SAID THE PT WOULD BITE DOWN ON SOMETHING AND SHEAR A TOOTH AT THE GUM LINE. THEY WOULD DRILL THE REST OF THE TOOTH OUT AND REPLACE THE TOOTH. THERE WAS NO INCIDENT OF A PT BEING INJURED FROM THIS, NO ASPIRATION OR INGESTION. ON (B)(6) 2013, SENT A LIST OF QUESTIONS FOR THE LAB CONCERNING THE SHEARING OF TEETH. THE LAB DECLINED TO RESPOND TO THESE QUESTIONS. THE LAB NO LONGER HAS THE TEETH THEREFORE THEY WILL NOT BE RETURNING THEM FOR EVAL. THIS INCIDENT INVOLVED DENTURE TOOTH #9. (B)(4).