FDA Adverse Event
Injury
Summary report: N
ANK C/X IMPL A9.5/D3.5/L9.5
MDR report key: 21632119
·
Received March 18, 2025
Report
- Report Number
- 3013111692-2025-07250
- Event Type
- Injury
- Date Received
- March 18, 2025
- Date of Event
- January 21, 2025
- Report Date
- August 20, 2025
- Manufacturer
- DENTSPLY IMPLANTS MANUFACTURING GMBH
- Product Code
- DZE
- UDI-DI
- 07392532206061
- PMA / PMN Number
- K140347
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THEREFORE, BECAUSE A SERIOUS INJURY RESULTED, THIS EVENT 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.
Additional Manufacturer Narrative · 0
DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM ANK C/X IMPL A9.5/D3.5/L9.5 CATALOG # 17-0543 TO ANK IMPL A9,5 D3,5 MM/L9,5 MM CATALOG # 31010208. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION.
Additional Manufacturer Narrative · 0
UPDATED PRODUCT FROM (B)(4).
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 |
|---|---|---|---|---|---|---|---|
| 508732 | ANK C/X IMPL A9.5/D3.5/L9.5 | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | DENTSPLY IMPLANTS MANUFACTURING GMBH | UNK | 07392532206061 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |