MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-25 for SONICFILL COMPOSITE 35183 manufactured by Kerr Corporation.
[134201269]
The lot number 6793539 is a lot number the complainant suspects was involved in the incident, complainant is unable to confirm. No patient information was provided in regards to ethnicity, and race. The product was not returned, therefore no evaluation can be conducted.
Patient Sequence No: 1, Text Type: N, H10
[134201270]
A complainant alleged that upon activating the sonicfill handpiece the tip ejected forcefully hitting another tooth causing it to break. All pieces were recovered and no other injury occurred. The broken tooth required a crown placement. No emergency treatment required and no medication required. It was reported that patient has fully recovered with no other injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024312-2019-00001 |
| MDR Report Key | 8280032 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-25 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2019-01-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PAULO CALLE |
| Manufacturer Street | 1717 W COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer G1 | KAVO KERR |
| Manufacturer Street | 1717 W COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92867 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SONICFILL COMPOSITE |
| Generic Name | TOOTH SHADE RESIN MATERIAL |
| Product Code | EBF |
| Date Received | 2019-01-25 |
| Catalog Number | 35183 |
| Lot Number | 6793539 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KERR CORPORATION |
| Manufacturer Address | 1717 W.COLLINS AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-25 |