FDA Adverse Event
Injury
Summary report: N
M4 INTERNAL HEX. IMPLANT DIA. 3.75 L 13MM
MDR report key: 22813146
·
Received August 15, 2025
Report
- Report Number
- 3004203816-2025-35202
- Event Type
- Injury
- Date Received
- August 15, 2025
- Date of Event
- June 23, 2025
- Report Date
- September 17, 2025
- Manufacturer
- MIS IMPLANTS TECHNOLOGIES LTD.
- Product Code
- DZE
- UDI-DI
- 07290108991758
- PMA / PMN Number
- K112162
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM C1 CONI. CON. IMPLANT D3.75 L13MM, SP CATALOG # C1-13375 TO M4 INTERNAL HEX. IMPLANT DIA. 3.75 L 13MM CATALOG # MF4-13375. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING UDI # FROM TO (B)(4). THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.
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 BREAKAGE AND IMPLANT LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1225723 | M4 INTERNAL HEX. IMPLANT DIA. 3.75 L 13MM | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | MIS IMPLANTS TECHNOLOGIES LTD. | UNK | 07290108991758 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |