FDA Adverse Event
Injury
Summary report: N
IMPL TAPERED SP 4.8MM 8MM OCTAGON
MDR report key: 15815319
·
Received November 17, 2022
Report
- Report Number
- 0002023141-2022-02890
- Event Type
- Injury
- Date Received
- November 17, 2022
- Date of Event
- October 14, 2022
- Report Date
- March 15, 2023
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024017597
- PMA / PMN Number
- K082639
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL PMA/510(K) NUMBER ¿ K011245 / K002188.
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
IT WAS REPORTED THAT IT WAS IMPOSSIBLE TO SEPARATE THE MOUNT FROM THE IMPLANT DURING PLACEMENT RESULTING IN THE IMPLANT BEING REMOVED.
Description of Event or Problem · 0
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 168897 | IMPL TAPERED SP 4.8MM 8MM OCTAGON | DENTAL IMPLANT | DZE | ZIMMER DENTAL | SPWB8 | 2022040034 | 00889024017597 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |