FDA Adverse Event
Injury
Summary report: N
C1 CONI. CON. IMPLANT D3.75 L13MM, SP
MDR report key: 21475205
·
Received February 26, 2025
Report
- Report Number
- 3004203816-2025-12354
- Event Type
- Injury
- Date Received
- February 26, 2025
- Report Date
- February 26, 2025
- Manufacturer
- MIS IMPLANTS TECHNOLOGIES LTD.
- Product Code
- DZE
- PMA / PMN Number
- K112162
- 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. THIS MDR REPORT IS A LATE SUBMISSION. A CAPA (NCR2405716) HAS BEEN ISSUED.
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 |
|---|---|---|---|---|---|---|---|
| 1301894 | C1 CONI. CON. IMPLANT D3.75 L13MM, SP | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | MIS IMPLANTS TECHNOLOGIES LTD. | W22011971 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Female | Required Intervention |