ANK C/X IMPL A8/D3.5/L8
Report
- Report Number
- 3013111692-2022-11219
- Event Type
- Injury
- Date Received
- June 23, 2022
- Date of Event
- March 7, 2022
- Report Date
- August 2, 2022
- Manufacturer
- DENTSPLY IMPLANTS MANUFACTURING GMBH
- Product Code
- DZE
- PMA / PMN Number
- K041509
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
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.
AFTER RECEIVING ADDITIONAL INFORMATION AND INVESTIGATION THIS EVENT IS AN IMPLANT LOSS; PLEASE DISREGARD FOLLOW-UP REPORT # 1. CATALOG NUMBER IS ALSO BEING UPDATED FROM 17-1152 TO 31010405. ALSO UPDATING CODING FOR THIS EVENT. THIS IS TO CORRECT AND REMOVE THE CODES THAT WERE INITIALLY REPORTED - REMOVING CODES FOR: MEDICAL DEVICE PROBLEM CODE - 1863 THE CORRECTED CODES FOR THIS COMPLAINT ARE: MEDICAL DEVICE PROBLEM CODE - 2408.
ADDITIONAL INFORMATION RECEIVED INDICATING THIS IS NOT A IMPLANT LOSS EVENT AND IS NOT RELATED TO AN IMPLANT DEVICE. PLEASE DISREGARD THIS REPORT.
THE DATE RECEIVED BY MANUFACTURER (G3) WAS INCORRECT IN THE INITIAL REPORT. THE VALUE HAS BEEN CORRECTED IN THIS FOLLOW-UP REPORT.
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1400925 | ANK C/X IMPL A8/D3.5/L8 | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | DENTSPLY IMPLANTS MANUFACTURING GMBH | B190011478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female | Required Intervention |