MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-07-29 for EXTR. FCPS, GRIP DEEP 150 DEFDG150 manufactured by Integra York, Pa Inc..
[4844238]
Customer initially reports device not working properly. On (b)(6) 2014 doctor reports device is not gripping parallel, and is sliding around tooth where it is supposed to grip a root. Tooth broke off causing doctor the need to cut the tooth to remove it, extending the procedure beyond the norm. No harm to patient. Event took place in (b)(6), no detail available about age or gender of the patient.
Patient Sequence No: 1, Text Type: D, B5
[12347558]
To date the device involved in the reported incident has not been rec'd for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2014-00053 |
| MDR Report Key | 4030845 |
| Report Source | 06,08 |
| Date Received | 2014-07-29 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-06-02 |
| Date Mfgr Received | 2014-07-24 |
| Date Added to Maude | 2014-09-02 |
| 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 DRIVE |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTR. FCPS, GRIP DEEP 150 |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EMG |
| Date Received | 2014-07-29 |
| Catalog Number | DEFDG150 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2014-07-29 |