FDA Adverse Event
Injury
Summary report: N
SYBRONPRO TL
MDR report key: 2982172
·
Received February 19, 2013
Report
- Report Number
- 2016150-2013-00006
- Event Type
- Injury
- Date Received
- February 19, 2013
- Date of Event
- January 17, 2013
- Report Date
- February 19, 2013
- Manufacturer
- EBI, INC.
- Product Code
- DZE
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- CO, US
- Reporter Occupation
- DENTIST
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2013, THE PATIENT RETURNED TO HAVE HER BRACES REMOVED. TO DATE, THE PATIENT IS DOING FINE.
Additional Manufacturer Narrative · 1
DURING A FOLLOW UP WITH THE DOCTOR, SHE REPORTED THAT THEY HAD DECIDED TO REMOVE THE BRACKETS OFF THE PATIENT. REGULATORY AFFAIRS WILL UPDATE THIS COMPLAINT IF ANY FURTHER INFORMATION IS RECEIVED.
Description of Event or Problem · 1
ON (B)(6) 2013, A DOCTOR REPORTED THAT A PATIENT WENT IN FOR A ROUTINE VISIT. AFTER TAKING X-RAYS OF HER SYBRONPRO IMPLANTS, ONE SHOWED UP WITH A DARK HALO AROUND THE TIP OF THE APEX. AREA WAS OPENED UP. DOCTOR FOUND AN INFECTION AND REMOVED THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 71426 | SYBRONPRO TL | IMPLANT, PRODUCT CODE: DZE | DZE | EBI, INC. | 091039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |