FDA Adverse Event
Injury
Summary report: N
PROFILE BIABUT 4.0 -Ø5.5
MDR report key: 24437135
·
Received February 24, 2026
Report
- Report Number
- 3013111692-2026-07101
- Event Type
- Injury
- Date Received
- February 24, 2026
- Date of Event
- February 10, 2026
- Report Date
- February 27, 2026
- Manufacturer
- DENTSPLY IMPLANTS MANUFACTURING GMBH
- Product Code
- DZE
- UDI-DI
- 07392532108310
- PMA / PMN Number
- K974738
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DEVICE RECEIVED FOR THIS EVENT IS BEING CORRECTED FROM OSSEOSPEED TX 4.0S - 11 MM CATALOG#: 24942 TO PROFILE BIABUT 4.0 -Ø5.5 CATALOG#: 24191. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. CORRECTING 510 # FROM K053384 TO K974738. THIS IS A FOLLOW UP REPORT FOR THIS CORRECTED INFORMATION. REMOVING UDI#: (B)(4). THIS IS A FOLLOW UP REPORT FOR THE REMOVAL OF THIS UDI#.
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 |
|---|---|---|---|---|---|---|---|
| 487415 | PROFILE BIABUT 4.0 -Ø5.5 | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | DENTSPLY IMPLANTS MANUFACTURING GMBH | UNKNOWN | 07392532108310 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention | NOT PROVIDED. |