FDA Adverse Event
Injury
Summary report: N
SYBRONPRO XRT
MDR report key: 2110043
·
Received June 1, 2011
Report
- Report Number
- 2016150-2011-00124
- Event Type
- Injury
- Date Received
- June 1, 2011
- Date of Event
- December 28, 2010
- Report Date
- May 16, 2011
- Manufacturer
- EBI INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- NV, US
- Reporter Occupation
- DENTIST
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011 A DOCTOR ALLEGED THAT A PATIENT LOST A SYBRONPRO XRT IMPLANT APPROXIMATELY FOUR (4) MONTHS AFTER PLACEMENT DUE TO UNKNOW CAUSES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYBRONPRO XRT | IMPLANT, ENDOSSEOUS, ROOT-FORM | DZE | EBI INC. | 091033/092022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Congenital Anomaly| O| R |