IVORY CLAMP
Received Apr 29, 2015 · Event occurred Apr 14, 2015
Report 1821514-2015-00018 · MDR key 4736161
Device
Generic name
Clamp, Rubber Dam
Manufacturer
Heraeus Kulzer, LlcModel number
IVORY CLAMP SS 12ACatalog number
50057348
Lot number
I3
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
DENTAL ASSISTANT REPORTS AN IVORY CLAMP SS 12A REG MOLAR BROKE IN A PATIENT'S MOUTH TODAY. THE CLAMP BROKE INTO TWO PIECES AND BOTH PIECES WERE CAUGHT BY THE RUBBER DAM MATERIAL. WHEN ASKED, THE DA SAID THEY WERE USING HU-FRIEDY RUBBER DAM FORCEPS. I RECOMMENDED IN THE FUTURE THAT THEY USE ONLY GENUINE IVORY RUBBER DAM FORCEPS WHICH ARE STAMPED "MADE IN USA", AS THESE FORCEPS ARE THE ONES MANUFACTURED TO SPECIFICATIONS OF THE CLAMP EXTENSION. OTHER FORCEPS MAY ALLOW THE PRONGS TO OPEN TOO FAR AND HYPER EXTEND THE WINGS OF THE CLAMP, POTENTIALLY LEADING TO FRACTURE. AGREED TO REPLACE IVORY CLAMP SS 12A REG MOLAR.
Additional Manufacturer Narrative
ALTHOUGH WE HAVE NOT ESTABLISHED THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, WE'RE REPORTING IT TO BE COMPLIANT WITH 21 CFR PART 803 AND OUT OF AN ABUNDANCE OF CAUTION. THE RUBBER DAM CLAMP HAS BEEN THROWN AWAY BY THE DENTAL STAFF.