MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-13 for SCREW-VENT DENTAL IMPLANT SVP16 manufactured by Core-vent Bio-engineering.
[12353]
Dental implant broke in function.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2028280-1995-01118 |
| MDR Report Key | 23739 |
| Date Received | 1995-07-13 |
| Date of Report | 1995-07-12 |
| Date Facility Aware | 1995-07-12 |
| Report Date | 1995-07-12 |
| Date Reported to FDA | 1995-07-12 |
| Date Reported to Mfgr | 1995-07-12 |
| Date Added to Maude | 1995-07-26 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCREW-VENT DENTAL IMPLANT |
| Generic Name | ENDOSTEAL DENTAL IMPLANT |
| Product Code | DZG |
| Date Received | 1995-07-13 |
| Model Number | SVP16 |
| Lot Number | CV312017 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24053 |
| Manufacturer | CORE-VENT BIO-ENGINEERING |
| Manufacturer Address | 27030 MALIBU HILLS ROAD CALABAS HILLS CA 91301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-07-13 |