MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-24 for SYBRONENDO 973-0322 manufactured by Sybronendo.
[109619146]
Specific information with regard to the exact number of patients affected, genders, ages, and weights was not provided. The date of event was not provided. Device manufacture date is pending. The doctor reported that when root canals failed extractions had to be done and implants inserted. The product has been identified as an affected product in an ongoing class ii recall; therefore, no further evaluation is necessary.
Patient Sequence No: 1, Text Type: N, H10
[109619147]
A doctor alleged that there were cases were postoperative sensitivity and root canal failure had occured when using the elements obturation unit with buchanan tips.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2018-00019 |
| MDR Report Key | 7543397 |
| Date Received | 2018-05-24 |
| Date of Report | 2018-05-24 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-05-24 |
| 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 | DENTIST |
| 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 Phone | 7145167752 |
| Manufacturer G1 | SYBRONENDO |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0413-2018 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYBRONENDO |
| Generic Name | ELEMENTS OBTURATION UNIT, |
| Product Code | EKZ |
| Date Received | 2018-05-24 |
| Catalog Number | 973-0322 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYBRONENDO |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-24 |