FDA Adverse Event
Injury
Summary report: N
S ATLANTIS ABUTMENT ZR 10
MDR report key: 14434863
·
Received May 19, 2022
Report
- Report Number
- 1222802-2022-00002
- Event Type
- Injury
- Date Received
- May 19, 2022
- Date of Event
- April 1, 2022
- Report Date
- May 18, 2022
- Manufacturer
- DENTSPLY IH INC.
- Product Code
- NHA
- PMA / PMN Number
- MULTIPLE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- 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.
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 |
|---|---|---|---|---|---|---|---|
| 286651 | S ATLANTIS ABUTMENT ZR 10 | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | NHA | DENTSPLY IH INC. | 7589554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention | ANKYLOS C/X - DIAMETER AND LENGTH UNK. |