FDA Adverse Event
Injury
Summary report: N
ADVAN SYNC
MDR report key: 2149739
·
Received July 5, 2011
Report
- Report Number
- 2016150-2011-00139
- Event Type
- Injury
- Date Received
- July 5, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 8, 2011
- Manufacturer
- ORMCO CORPORATION
- Product Code
- DYJ
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON (B)(6) 2011, A CUSTOMER INFORMED ORMCO CORPORATION THAT WHEN REMOVING THE ADVANCSYNC APPLIANCE FROM TOOTH (#3 UPPER-RIGHT, 1ST MOLAR), THE MESIO-BUCCAL CUSP FRACTURED. PATIENT WENT TO DENTIST FOR RESTORATION OF THE TOOTH AND IS DOING FINE. NO INFORMATION REGARDING LOT NUMBER WAS RECEIVED. NO EVALUATION COULD BE CONDUCTED. NOT RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
ON (B)(6) 2011, A CUSTOMER INFORMED ORMCO CORPORATION THAT A MESIO-BUCCAL CUSP HAD FRACTURED WHEN REMOVING AN ADVANCSYNC APPLIANCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADVAN SYNC | BITE-JUMPING ORTHODONTIC APPLIANCE | DYJ | ORMCO CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | MULTI-CURE GLASS IONOMER CEMENT BY 3M |