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 NOBELACTIVE INTERNAL NP 3.5X10MM 34125 manufactured by Nobel Biocare Ab.
[185843101]
Implant failed due to a loss of osseointegration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611993-2020-20134 |
| MDR Report Key | 9907612 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-31 |
| Date of Event | 2020-02-17 |
| Device Manufacturer Date | 1999-01-01 |
| 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 AB |
| Manufacturer Street | DIMBOV |
| Manufacturer City | KARLSKOGA 69151 |
| Manufacturer Country | SE |
| Manufacturer Postal Code | 69151 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOBELACTIVE INTERNAL NP 3.5X10MM |
| Generic Name | ENDOSSEOUS DENTAL IMPLANT |
| Product Code | DZE |
| Date Received | 2020-03-31 |
| Catalog Number | 34125 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOBEL BIOCARE AB |
| Manufacturer Address | DIMBOV?GEN 2 KARLSKOGA 69151 SE 69151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |