FDA Adverse Event
Injury
Summary report: N
ENDOPORE ABUTMENT
MDR report key: 1802144
·
Received August 17, 2010
Report
- Report Number
- 2016150-2010-00112
- Event Type
- Injury
- Date Received
- August 17, 2010
- Report Date
- July 7, 2010
- Manufacturer
- SYBRON IMPLANT SOLUTIONS
- Product Code
- NHA
- PMA / PMN Number
- K952434
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE DOCTOR REPORTED THAT AN ENDOPORE ABUTMENT FRACTURED. AN EVALUATION COULD NOT BE CONDUCTED ON THE FRACTURED ABUTMENT, AS THE DOCTOR REFUSED TO RETURN IT TO SYBRON IMPANT SOLUTIONS. NO X-RAYS WERE PROVIDED BY THE DOCTOR, NOR WERE ANY DETAILS REGARDING PATIENT OUTCOME. NO LOT NUMBER WAS PROVIDED FOR THE ABUTMENT, THEREFORE A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED AND NO FURTHER INVESTIGATION IS POSSIBLE. HOWEVER, IT WAS CONFIRMED THAT THE FRACTURE WAS DUE TO USER ERROR, AS THE DOCTOR STATED THAT HE CAUSED THE FRACTURE.
Description of Event or Problem · 1
ON JULY 7, 2010, A DOCTOR REPORTED TO SYBRON IMPLANT SOLUTIONS THAT AN ENDOPORE ABUTMENT FRACTURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPORE ABUTMENT | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS | NHA | SYBRON IMPLANT SOLUTIONS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |