FDA Adverse Event
Injury
Summary report: N
IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM
MDR report key: 19196686
·
Received April 26, 2024
Report
- Report Number
- 0002023141-2024-01333
- Event Type
- Injury
- Date Received
- April 26, 2024
- Date of Event
- September 12, 2023
- Report Date
- September 4, 2024
- Manufacturer
- ZIMMER DENTAL
- Product Code
- DZE
- UDI-DI
- 00889024020108
- PMA / PMN Number
- K061410
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: EMAIL UNKNOWN / NOT PROVIDED. G4: PMA/510(K) NUMBER K013227.
Additional Manufacturer Narrative · 0
ZIMVIE COMPLAINT NUMBER (B)(4). A4: PATIENT WEIGHT UNKNOWN / NOT PROVIDED. E1: EMAIL UNKNOWN / NOT PROVIDED. G4: PMA/510(K) NUMBER K013227.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO PERIIMPLANTITIS. PATIENT HAD INFLAMMATION ON GUM TISSUE SURROUNDING IMPLANT AND BONE LOSS SYMPTOMS AS A RESULT OF THE EVENT: BONE LOSS, INFLAMMATION
Description of Event or Problem · 0
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2122640 | IMPL TAPERED SCR-V HA 4.7 MM 4.5MM 11.5MM | DENTAL IMPLANT | DZE | ZIMMER DENTAL | 1240821 | 00889024020108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |