FDA Adverse Event
Injury
Summary report: N
C1-13330
MDR report key: 23537492
·
Received November 12, 2025
Report
- Report Number
- 3004203816-2025-42418
- Event Type
- Injury
- Date Received
- November 12, 2025
- Report Date
- November 12, 2025
- Manufacturer
- MIS IMPLANTS TECHNOLOGIES LTD.
- Product Code
- DZE
- UDI-DI
- 07290108992120
- PMA / PMN Number
- K172505
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
SINCE THIS EVENT RESULTED IN A SERIOUS INJURY, IT IS REPORTABLE PER 21 CFR PART 803. THE DEVICE WAS NOT EVALUATED BECAUSE THE ISSUE IS A KNOWN INHERENT RISK OF THE DEVICE. WE WILL CONTINUE TO TRACK AND MONITOR THE TREND.
Description of Event or Problem · 0
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2593970 | C1-13330 | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | MIS IMPLANTS TECHNOLOGIES LTD. | W23004027 | 07290108992120 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |