FDA Adverse Event
Injury
Summary report: N
SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML
MDR report key: 21327780
·
Received February 6, 2025
Report
- Report Number
- 3001617766-2025-005432
- Event Type
- Injury
- Date Received
- February 6, 2025
- Date of Event
- September 23, 2024
- Manufacturer
- IMPLANT DIRECT SYBRON MANUFACT
- Product Code
- DZE
- UDI-DI
- 10841307125082
- PMA / PMN Number
- K201553
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
UPON INSPECTION OF PART IT WAS FOUND TO BE 674213NP NOT 674211NP. DI # (B)(4), PREMARKET SUBMISSION # K201553.
Description of Event or Problem · 0
FAILURE TO OSSEOINTEGRATE
Description of Event or Problem · 0
FAILURE TO OSSEOINTEGRATE.
Description of Event or Problem · 0
FAILURE TO OSSEOINTEGRATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 622790 | SIMPLY ICONIC SBM IMP 4.2X3.0 PLAT 13MML | ENDOSSEOUS DENTAL IMPLANT | DZE | IMPLANT DIRECT SYBRON MANUFACT | 15002742 | 10841307125082 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Female | Required Intervention |