| 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 | 12A REGMOLAR | 50057348 | A3 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-03-11 | 0 |
Patient 1
THIS TOOK PLACE IN (B)(6). TO: (B)(4). SUBJECT: COMPLAINT RUBBER DAM CLAMP. DEAR MR. (B)(4), I RECEIVED A BROKEN RUBBER DAM CLAMP BACK#12A FROM A CUSTOMER. WOULD YOU LIKE ME TO SEND IT BACK TO YOU FOR SOME KIND OF INVESTIGATION. THEREFOR I NEED AN RMA#, I THINK. THANK YOU. REGARDS (B)(6).
Patient 1
NARRATIVE FOR RESULTS - USAGE BEYOND THE STATED USE LIFE OF ONE YEAR AND DISTORTING THE CLAMP DURING USAGE CAUSING BREAKAGE OF THE CLAMP. NARRATIVE FOR CONCLUSION - 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. ANALYSIS OF RETURNED BROKEN CLAMP. ITEM EVALUATED: IVORY CLAMP SS 12A REG MOLAR LOT NO.: A3, MANUFACTURE DATE: 09/28/2013, RECEIPT DATE: 02/24/2015, COMPLAINT: BROKEN. EVALUATION SUMMARY: ONLY A FRAGMENT OF THE CLAMP WAS RECEIVED FOR ANALYSIS. THE CLAMP BROKE IN THE BOW AREA, LOWER BY THE WING. THE DFU STATES, "CAUTION: MODIFICATION, OVER-EXTENDING, BENDING, OR USE EXCEEDING ONE YEAR MAY CAUSE BREAKAGE." CAUSE OF BREAKAGE: THE RETURNED FRAGMENT WAS TOO SMALL TO EVALUATE. CONCLUSION: THE COMPLAINT IS NOT CONFIRMED AS A QUALITY DEFECT DUE TO LACK OF INFORMATION. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THE INVESTIGATION IS CLOSED. CAPA MEASURES ARE NOT PROPOSED OR INITIATED.