MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-10-15 for CERAGLAZE PORCELAIN POLISHER (PRE-POLISH) P353-3 manufactured by Axis Dental Corp..
[972059]
A patient alleges the dentist had performed a root canal on tooth no. 29 and had placed a pre-formed post and crown. During the treatment the polishing bur shattered and fractured the tooth. Some of the pieces of the polishing bur were ingested by the patient, and the patient had to seek medical attention. No report from the dentist was received regarding the alleged incident.
Patient Sequence No: 1, Text Type: D, B5
[8229359]
Possible adverse event was reported to the mfr through an attorney of the patient. Notification alleges that the p353-3 polisher (purchased in our ls-514 logic set) shattered while adjusting a pre-formed ceramic crown. The specific lot number is not available as the instrument was disposed of by the doctor on the day of the incident. Neither the dealer company nor date of purchase is known. Since neither the lot number nor date of purchase can be determined, we tested polishers taken from current stock. We polished a ceramic crown with three p353-3 polishers, lot number s12. 003, at a speed of less than 5000 rpm. Polishers performed according to expectations. No breakage or fragmenting was observed. We have received no other complaints of this nature involving this item.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1645240-2008-11002 |
| MDR Report Key | 1198460 |
| Report Source | 04 |
| Date Received | 2008-10-15 |
| Date of Report | 2006-12-27 |
| Date of Event | 2006-04-24 |
| Date Mfgr Received | 2006-12-27 |
| Date Added to Maude | 2008-10-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 800 W. SANDY LAKE RD. SUITE 100 |
| Manufacturer City | COPPELL TX 75019 |
| Manufacturer Country | US |
| Manufacturer Postal | 75019 |
| Manufacturer Phone | 4696356100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CERAGLAZE PORCELAIN POLISHER (PRE-POLISH) |
| Generic Name | SMALL CONE SHAPED POLISHING POINT (EHL) |
| Product Code | EHJ |
| Date Received | 2008-10-15 |
| Model Number | P353-3 |
| Catalog Number | P353-3 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1243661 |
| Manufacturer | AXIS DENTAL CORP. |
| Manufacturer Address | COPPELL TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2008-10-15 |