FDA Adverse Event
Malfunction
Summary report: N
MONO IMPLANT
MDR report key: 17077773
·
Received June 7, 2023
Report
- Report Number
- 3011390931-2023-00001
- Event Type
- Malfunction
- Date Received
- June 7, 2023
- Date of Event
- June 23, 2021
- Report Date
- June 7, 2023
- Manufacturer
- NORIS MEDICAL LTD
- Product Code
- DZE
- UDI-DI
- 07290108814606
- PMA / PMN Number
- K140440
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
UDI RELATED DATA QUALITY UPDATES ONLY.
Description of Event or Problem · 0
LABEL OF TUFF IMPLANT WAS ON PACKAGE WITH MONO IMPLANT. IT WAS IDENTIFIED BY THE EMPLOYEE OF NORIS MEDICAL INC - SUBSIDIARY OF NORIS MEDICAL LTD ( IMPORTER - DISTRIBUTOR) IN THE STOCK WAREHOUSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508928 | MONO IMPLANT | MONO DENTAL IMPLANT | DZE | NORIS MEDICAL LTD | NM-V3311 | 7000487 | 07290108814606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |