MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-31 for NOBELREPLACE CC PMC RP 4.3X8MM 37290 manufactured by Nobel Biocare Usa Inc.
[185884479]
Implant failed due to failure to osseointegrate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027971-2020-08891 |
| MDR Report Key | 9907602 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Device Manufacturer Date | 2019-10-25 |
| Date Added to Maude | 2020-03-31 |
| 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 | WILLEM VAN ALST |
| Manufacturer Street | KOZAKKENBERG 4 |
| Manufacturer City | BELFELD 5951DL |
| Manufacturer Country | NL |
| Manufacturer Postal | 5951 DL |
| Manufacturer Phone | 683284947 |
| Manufacturer G1 | NOBEL BIOCARE USA INC |
| Manufacturer Street | 22725 SAVI RANCH |
| Manufacturer City | YORBA LINDA CA 928874609 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 928874609 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOBELREPLACE CC PMC RP 4.3X8MM |
| Generic Name | ENDOSSEOUS DENTAL IMPLANT |
| Product Code | DZE |
| Date Received | 2020-03-31 |
| Catalog Number | 37290 |
| Lot Number | 13090180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOBEL BIOCARE USA INC |
| Manufacturer Address | 22725 SAVI RANCH YORBA LINDA CA 928874609 US 928874609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |