FDA Adverse Event
Injury
Summary report: N
NOBRPL TAPERED GROOVY NP 3.5X11.5MM
MDR report key: 12774206
·
Received November 8, 2021
Report
- Report Number
- 9611993-2021-104501
- Event Type
- Injury
- Date Received
- November 8, 2021
- Manufacturer
- NOBEL BIOCARE AB
- Product Code
- DZE
- PMA / PMN Number
- K050258
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE PRESENT SUBMISSION/SUBMISSIONS IS/ARE CORRECTIVE SUBMISSION/SUBMISSIONS FOR THE INCORRECT MFG. SUBMISSION/SUBMISSIONS RELATED TO QN (B)(4). THE CORRECTIVE ACTION HAS BEEN TAKEN UNDER FDA CDRH EMDR [email protected] GUIDANCE.
Description of Event or Problem · 0
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.
Description of Event or Problem · 0
IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM. THE PRESENT SUBMISSION/SUBMISSIONS IS/ARE CORRECTIVE SUBMISSION/SUBMISSIONS FOR THE INCORRECT MFG. SUBMISSION/SUBMISSIONS RELATED TO QN (B)(4). THE CORRECTIVE ACTION HAS BEEN TAKEN UNDER FDA CDRH EMDR [email protected] GUIDANCE. DEATH WAS SELECTED IN ERROR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1672361 | NOBRPL TAPERED GROOVY NP 3.5X11.5MM | ENDOSSEOUS DENTAL IMPLANT | DZE | NOBEL BIOCARE AB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Death| R |