FDA.reportPublic FDA data

MAUDE MDR 501348

MDR report key
501348
Report number
1925223-2003-00001
Event key
0
Event type
3
Date received
2003-12-12
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#

Contact
CHERYL ZIMMERMAN
Address
4315 S. LAFAYETTE BLVD. SOUTH BEND IN 46614 US
Phone
574-574-5742
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FORCEP RD57220HERAEUS KULZER, INC.EJG50057220*NANYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-12-1201. R

Event Narratives#

D

Patient 1

RUBBER DAM FORCEPS BROKE DURING TREATMENT AND A PATIENT WAS HURT. AWAITING FURTHER DETAILS. DENTIST USES THE RUBBER DAM TECHNIQUE QUITE OFTEN AND SO HE BOUGHT SEVERAL FORCEPS OVER THE LAST YEARS. HE CAN'T REALLY TELL WHEN HE BOUGHT THE FORCEPS, WHICH BROKE NOW. AS FAR AS STERILIZATION IS CONCERNED THERE IS NOTHING UNUSUAL: HE USES A "THERMODISINFECTOR" AND FROM TIME TO TIME HE USES ALSO AN AUTOCLAVE. RECEIVED LETTER STATING THE FORCEPS FRACTURED WHEN PLACING A RUBBER DAM CLAMP ON TOOTH 47. THE RETURN SPRING CAUSED A MASSIVE FRACTURE IN THE DENTAL-LINGUAL PORTION OF A NEIGHBORING TOOTH (47). THE DAMAGED TOOTH WAS HEALTHY WITH THE EXCEPTION OF A SMALL OCCLUSAL FILLING. IT RESULTED IN THE TEMPORARY RESTORATION OF THE OPEN DENTIN WOUND WITH AN ADHESIVE COMPOSITE. ADEQUATE TREATMENT WITH POSSIBLE GRATED SUBSTANCE PRESERVATIONS, LIKELY REPLACEMENT WITH FULL CROWN.