FDA Adverse Event
Malfunction
Summary report: N
NEOCIS GUIDANCE SYSTEM
MDR report key: 15810480
·
Received November 16, 2022
Report
- Report Number
- 3012787974-2022-80056
- Event Type
- Malfunction
- Date Received
- November 16, 2022
- Date of Event
- October 17, 2022
- Report Date
- December 28, 2022
- Manufacturer
- NEOCIS INC.
- Product Code
- PLV
- UDI-DI
- 00810004900004
- PMA / PMN Number
- K210711
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS MDR 3012787974-2022-80056 FOLLOWUP IS SUBMITTED TO UPDATE ADVERSE EVENT PROBLEM CODES ORIGINALLY SUBMITTED IN 3012787974-2022-80056 ON NOV 15, 2022 BASED ON RESULTS OF THE INVESTIGATION.
Description of Event or Problem · 0
FOR A PLANNED IMPLANT PLACEMENT, OSTEOTOMY WAS EXECUTED TOO BUCCAL. SURGEON DECIDED TO CORRECT OSTEOTOMY FREEHAND AND PLACE IMPLANT FREEHAND. NO FURTHER INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 0
FOR A PLANNED IMPLANT PLACEMENT, OSTEOTOMY WAS EXECUTED TOO BUCCAL. SURGEON DECIDED TO CORRECT OSTEOTOMY FREEHAND AND PLACE IMPLANT FREEHAND. NO FURTHER INJURY OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1830784 | NEOCIS GUIDANCE SYSTEM | DENTAL STEREOTAXIC INSTRUMENT | PLV | NEOCIS INC. | GEN 1 | N/A | 00810004900004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |