MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-09-13 for NEOCIS GUIDANCE SYSTEM GEN 1 manufactured by Neocis Inc..
| Report Number | 3012787974-2019-80002 |
| MDR Report Key | 9030243 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-09-13 |
| Date of Report | 2019-08-20 |
| Date of Event | 2019-08-15 |
| Date Mfgr Received | 2019-08-15 |
| Device Manufacturer Date | 2019-06-19 |
| Date Added to Maude | 2019-09-13 |
| 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 | DR. THOMAS CLAIBORNE |
| Manufacturer Street | 2800 BISCAYNE BLVD. SUITE 600 |
| Manufacturer City | MIAMI FL 33137 |
| Manufacturer Country | US |
| Manufacturer Postal | 33137 |
| Manufacturer Phone | 8559636247 |
| Manufacturer G1 | NEOCIS INC. |
| Manufacturer Street | 555 NW 29TH ST |
| Manufacturer City | MIAMI FL 33127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOCIS GUIDANCE SYSTEM |
| Generic Name | DENTAL STEREOTAXIC INSTRUMENT |
| Product Code | PLV |
| Date Received | 2019-09-13 |
| Model Number | GEN 1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEOCIS INC. |
| Manufacturer Address | 2800 BISCAYNE BLVD. SUITE 600 MIAMI FL 33137 US 33137 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-09-13 |