MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-19 for PROCERA BRIDGE ZIRCONIA 4 UNIT MEDIUM 30-4003-10 manufactured by Nobel Biocare.
[80765969]
Referencing quality notification # (b)(4). Continued monitoring of all complaints of this type will continue to be conducted. No further corrective or preventive actions are planned.
Patient Sequence No: 1, Text Type: N, H10
[80765970]
Pigmentation, blue/gray discoloration of the mucosa. Pigmentation both against the lip and palate. According to the clinician, the discoloration is not amalgam tattoos.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003719670-2017-00002 |
| MDR Report Key | 6725352 |
| Date Received | 2017-07-19 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-09-26 |
| Date Mfgr Received | 2016-09-28 |
| Device Manufacturer Date | 2014-01-29 |
| Date Added to Maude | 2017-07-19 |
| 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 | MS. JOANN RADOVICH |
| Manufacturer Street | 22715 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7142824800 |
| Manufacturer G1 | NOBEL BIOCARE USA LLC |
| Manufacturer Street | 22715 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92887 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROCERA BRIDGE ZIRCONIA 4 UNIT MEDIUM |
| Generic Name | PROCERA BRIDGE |
| Product Code | NSN |
| Date Received | 2017-07-19 |
| Catalog Number | 30-4003-10 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOBEL BIOCARE |
| Manufacturer Address | PROCERA SANDVIK AB 12680 STOCKHOLM, SWEDEN 40226 SW 40226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-19 |