FDA Adverse Event
Malfunction
Summary report: N
ENDOPORE ABUTMENT
MDR report key: 1312664
·
Received February 17, 2009
Report
- Report Number
- 9681239-2009-00001
- Event Type
- Malfunction
- Date Received
- February 17, 2009
- Report Date
- January 20, 2009
- Manufacturer
- SYBRON IMPLANT SOLUTIONS CORP.
- Product Code
- NHA
- PMA / PMN Number
- K952434
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DOCTOR REPORTED THAT THE PATIENT IS DOING FINE AND THAT THE FRACTURED ABUTMENT WILL BE REPLACED. NO EVALUATION WAS PERFORMED: THE PRODUCT WAS NOT RETURNED TO SYBRON IMPLANT SOLUTIONS CORP. FOR EVALUATION.
Description of Event or Problem · 1
IN 2009, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS CORP. THAT AN ABUTMENT HAD FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPORE ABUTMENT | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | NHA | SYBRON IMPLANT SOLUTIONS CORP. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Other |