MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-25 for NEOCIS GUIDANCE SYSTEM GEN 1 NA manufactured by Neocis Inc..
[139706256]
The drill and drill motor are reusable parts. Rigidity inspections were previously on label. Neocis implemented field notification on 12-mar-2019 to remind users and field personnel to inspect the drill-to-drill motor connection for rigidity, as previously labeled. Loose drills should be removed from service and replaced with new drills. Drill face calibration is performed prior to each case to help ensure osteotomy accuracy. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139706257]
Guided osteotomy deviated from the plan and resulted in a breach of the buccal cortical plate. Defect repaired with xenograft membrane and bone. Plan deviation caused by rotation of the drill handpiece at the drill motor interface. The drill handpiece stabilization pin was found to be loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012787974-2019-80001 |
| MDR Report Key | 8448198 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-22 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-02-20 |
| Device Manufacturer Date | 2019-09-12 |
| Date Added to Maude | 2019-03-25 |
| 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 | 2800 BISCAYNE BLVD SUITE 600 |
| Manufacturer City | MIAMI FL 33137 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33137 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOCIS GUIDANCE SYSTEM |
| Generic Name | BONE CUTTING INSTRUMENT AND ACCESSORIES |
| Product Code | PLV |
| Date Received | 2019-03-25 |
| Returned To Mfg | 2019-02-28 |
| Model Number | GEN 1 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-25 |