FDA Adverse Event
Injury
Summary report: N
FIBREKOR POST
MDR report key: 2853554
·
Received December 3, 2012
Report
- Report Number
- 2024312-2012-00312
- Event Type
- Injury
- Date Received
- December 3, 2012
- Report Date
- November 2, 2012
- Manufacturer
- PENTRON CLINICAL
- Product Code
- ELR
- PMA / PMN Number
- K983266
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT'S FIBREKOR POST AND CROWN HAD SEPARATED FROM THE TOOTH STRUCTURE AS ONE (1) WHOLE UNIT. THE PATIENT DID NOT SWALLOW THE RESTORATION; THE RESTORATION WAS RETRIEVED. IT WAS CONFIRMED THAT THE A NEW CROWN AND POST HAVE BEEN PLACED; TO DATE, THE PATIENT IS DOING FINE. THE DOCTOR RETURNED PRODUCT BELIEVED TO BE ASSOCIATED WITH THE ALLEGED INCIDENT; HOWEVER, HE COULD NOT PROVIDE A LOT NUMBER AS THE PRODUCT HAD BEEN REMOVED FROM ITS ORIGINAL PACKAGING. THE RETURNED PRODUCT WAS VISUALLY INSPECTED AND WAS FOUND TO MEET PRODUCT SPECIFICATIONS.
Description of Event or Problem · 1
A DOCTOR'S OFFICE ALLEGED THAT ONE (1) PATIENT HAD EXPERIENCED A FRAYED FIBREKOR POST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIBREKOR POST | ROOT CANAL POST | ELR | PENTRON CLINICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | FUJI PLUS CEMENT |