| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IVORY CLAMP | CLAMP, RUBBER DAM | HERAEUS KULZER, LLC | EEF | 50057348 | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-04-11 | 0 |
Patient 1
(B)(6) 2014 RECEIVED FORWARDED EMAIL FROM A (B)(6) DEALER WITH THE FOLLOWING INFORMATION WITHIN IT: A DENTIST BOUGHT A CLAMP 12A ON (B)(6) 2012. IF YOU LOOK INVOICE COPY. IT'S BROKEN IN 2 PARTS. REQUEST THAT THE HK REP RETURN THE CLAMP FOR EVALUATION AND INFORMED THAT THE CLAMP WAS OUT OF WARRANTY. HK REP HAS TRIED TO RETRIEVE THE CLAMP FROM THE DEALER, BUT IT HAS NOT BEEN AVAILABLE.
Patient 1
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 DIRECTIONS FOR USE STATES, "CAUTION: MODIFICATION, OVER-EXTENDING, BENDING, OR USE EXCEEDING ONE YEAR MAY CAUSE BREAKAGE." DEVICE BREAKAGE IS ADDRESSED IN THE DIRECTIONS FOR USE. THE DIRECTIONS STATE, "DO NOT PLACE CLAMP IN MOUTH UNTIL THE RUBBER DAM HAS BEEN PROPERLY PLACED. CLAMP COULD BECOME A CHOKING OR SAFETY HAZARD IF DROPPED OR BROKEN IN THE MOUTH WITHOUT PROPER USE OF THE RUBBER DAM AT ALL TIMES. " THE CLAMP USAGE EXCEEDED THE USE LIFE OF ONE YEAR WHICH IS STATED AS THE USE LIFE IN THE DIRECTIONS FOR USE. NOT RETURNED/NO LOT INFO.