FDA Adverse Event
Injury
Summary report: N
PITT EASY ABUTMENT
MDR report key: 1400314
·
Received June 10, 2009
Report
- Report Number
- 9611820-2009-00011
- Event Type
- Injury
- Date Received
- June 10, 2009
- Report Date
- May 13, 2009
- Manufacturer
- SYBRON IMPLANT SOLUTIONS GMBH
- Product Code
- NHA
- PMA / PMN Number
- K053242
- Adverse Event
- 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. THE DOCTOR WILL REPLACE THE FRACTURED ABUTMENTS WITH NEW ABUTMENTS. THE DOCTOR RETURNED TWO SCREWS TO SYBRON IMPLANT SOLUTIONS GMBH FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PRODUCTS INDICATED THAT THE CAUSE OF THE ABUTMENT SCREW FRACTURES WAS OVERLOADING BY SUPERSTRUCTURE SINCE THE ENTIRE BRIDGE PROSTHESIS WAS ONLY SUPPORTED BY THESE THREE SCREWS AND WAS IN FUNCTION FOR MORE THAN 15 YEARS. THIS IS THE FIRST MDR REPORT OF THE TWO INCIDENTS REPORTED. THIS IS THE FINAL REPORT.
Description of Event or Problem · 1
IN 2009, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS GMBH THAT THREE PITT EASY IMPLANT ABUTMENT SCREWS HAD FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PITT EASY ABUTMENT | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | NHA | SYBRON IMPLANT SOLUTIONS GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other| R |