FDA Adverse Event
Injury
Summary report: N
BLT Ø4.8MM RC, SLACTIVE® 10MM, TIZR, NTP
MDR report key: 21754252
·
Received April 2, 2025
Report
- Report Number
- 0001222315-2025-000895
- Event Type
- Injury
- Date Received
- April 2, 2025
- Date of Event
- November 20, 2024
- Report Date
- November 28, 2025
- Manufacturer
- INSTITUT STRAUMANN AG
- Product Code
- DZE
- UDI-DI
- 07630031707444
- PMA / PMN Number
- K140878
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- UT, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NON-FATAL SERIOUS INJURY OR DEVICE MALFUNCTION STORED DUE TO COVID 19 PANDEMIC IN ACCORDANCE WITH FDA GUIDANCE "POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC" PUBLISHED MAY 2020.
Description of Event or Problem · 0
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 19. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. THE DEVICE WAS FORWARDED TO THE MANUFACTURER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Description of Event or Problem · 0
THE CLINICIAN REPORTS THE IMPLANT WAS INSERTED (B)(6) 2024 IN ADA 19. ON (B)(6) 2024, NON-OSSEOINTEGRATION WAS VERIFIED. NO PRODUCT WAS RETURNED TO THE MANUFACTU RER. THERE WERE NO REPORTED PATIENT INJURIES OR COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2302836 | BLT Ø4.8MM RC, SLACTIVE® 10MM, TIZR, NTP | ENDOSSEOUS DENTAL IMPLANT | DZE | INSTITUT STRAUMANN AG | GMJP3 | 07630031707444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Required Intervention |