MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-05-21 for VANTAGE 151 EXTR FCPS SER V90-151-SG manufactured by Integra York, Pa Inc..
[4671583]
Customer initially reported broken tip. On (b)(6) 2014 dental assistant reports no harm done, no risk for harm under the circumstances, measures to prevent swallowing pieces are used. Doctor was doing an extraction and one of the jaws broke off and was immediately retrieved.
Patient Sequence No: 1, Text Type: D, B5
[12146408]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2014-00028 |
| MDR Report Key | 3897123 |
| Report Source | 06 |
| Date Received | 2014-05-21 |
| Date of Report | 2014-04-28 |
| Date of Event | 2014-04-21 |
| Date Mfgr Received | 2014-04-28 |
| Date Added to Maude | 2014-07-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANTAGE 151 EXTR FCPS SER |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EMG |
| Date Received | 2014-05-21 |
| Catalog Number | V90-151-SG |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-21 |