FDA Adverse Event
Injury
Summary report: N
ENDOPORE ABUTMENT
MDR report key: 1366523
·
Received April 22, 2009
Report
- Report Number
- 9681239-2009-00003
- Event Type
- Injury
- Date Received
- April 22, 2009
- Report Date
- March 23, 2009
- Manufacturer
- SYBRON IMPLANT SOLUTIONS CORP.
- Product Code
- NHA
- PMA / PMN Number
- K952434
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE REPORTER, FROM THE DENTAL LABORATORY, REPORTED THAT AN ENDOPORE ABUTMENT HAD FRACTURED. HOWEVER, HE DID NOT PROVIDE ANY SPECIFIC INFORMATION REGARDING THE CAUSE OF THE ABUTMENT FRACTURE. THE DENTAL LAB REPORTED THAT THE PATIENT'S IMPLANT IS FINE. NO EVALUATION WAS PERFORMED: THE PRODUCT HAS NOT BEEN RETURNED TO SYBRON IMPLANT SOLUTIONS CORP. FOR EVALUATION.
Description of Event or Problem · 1
IN 2009, A DENTAL LABORATORY 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 | Other |