MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-31 for NOBELPARALLEL CC RP 4.3X8.5MM 37971 manufactured by Nobel Biocare Ab.
[185884828]
Implant failed due to a loss of osseointegration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027971-2020-08897 |
| MDR Report Key | 9907600 |
| Date Received | 2020-03-31 |
| Date of Event | 2020-03-12 |
| Date Facility Aware | 2020-03-28 |
| Report Date | 2020-03-31 |
| Date Reported to FDA | 2020-03-31 |
| Date Added to Maude | 2020-03-31 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOBELPARALLEL CC RP 4.3X8.5MM |
| Generic Name | ENDOSSEOUS DENTAL IMPLANT |
| Product Code | DZE |
| Date Received | 2020-03-31 |
| Catalog Number | 37971 |
| Lot Number | 12083457 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1098 DA |
| Device Eval'ed by Mfgr | * |
| 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 |