FDA.reportPublic FDA data

MAUDE MDR 6092667

MDR report key
6092667
Report number
8010252-2016-00001
Event key
0
Event type
3
Date of event
2016-09-20
Date received
2016-11-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
303
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. GOTTFRIED HIPP
Address
CARL-BENZ-STRASSE 1 NEUHAUSEN OB ECK, BADEN-WUERTTEMBERG 78579 GM
Phone
467-467-4671
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WYNMAN CARB CROWN GRIPPERCROWN REMOVERG. HIPP & SONEIS72-10TCY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-100

Event Narratives#

N

Patient 1

THE DEVICE WAS MANUFACTURED AND PUT INTO COMMERCIAL DISTRIBUTION PRIOR TO 1998, 18+ YEARS AGO. IT HAS BEEN USED LONG PAST ITS EXPECTED LIFE, BEING SUBJECT TO INTENSIVE REUSE, AS EVIDENCED BY ITS EXTREMELY WORN CONDITION, BOTH OVERALL AND OF THE INSERTS IN PARTICULAR.

D

Patient 1

FACILITY REPORTS THAT THE INSERT BROKE WHILE USING. THE DOCTOR REPORTS THAT HE WAS GRIPPING A CROWN WHEN A TIP OF THE CARBIDE INSERT BROKE OFF IN THE MOUTH AND WAS RETRIEVED. NO HARM DONE.