MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2014-08-21 for EXTR FCPS, GRIP DEEP 151 DEFDG151 manufactured by Integra York, Pa Inc.
[4759071]
Customer initially reports the device was not working properly. On (b)(6) 2014, doctor reports the device broke the tooth off because of uneven grip at the base of the tooth. Doctor had to cut the tooth out, no harm to pt, no excess bleeding. Event occurred in april or may. No other info available.
Patient Sequence No: 1, Text Type: D, B5
[12316994]
Integra has completed their internal investigation: methods: eval of actual device. Review of device history records. Review of complaint history. Results: investigation results: the returned forceps showing wear, discoloration, and staining. The forceps grip area appears to have minimal corrosion. The complaint is a customer preference issue the end user does not prefer the design of the forceps. Forceps dimensions are within specifications. The complaint is unconfirmed. Dhr review was completed with all history available variance authorization/deviation history: none. There is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: none. Health hazard eval history: none. Trend analysis: 2 complaints of this nature were identified. Conclusion: there were two extracting forceps, manufactured in december 2007, returned in used condition. Forceps dimensions are within specifications. The complaint is unconfirmed. Integra considers this complaint closed. Future incidents of this nature will be documented for recurrence and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2014-00055 |
| MDR Report Key | 4093174 |
| Report Source | 06,08 |
| Date Received | 2014-08-21 |
| Date of Report | 2014-07-24 |
| Date of Event | 2014-04-15 |
| Date Mfgr Received | 2014-07-29 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2014-09-24 |
| 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 | EXTR FCPS, GRIP DEEP 151 |
| Generic Name | M51 - GENERAL DENTISTRY |
| Product Code | EMG |
| Date Received | 2014-08-21 |
| Returned To Mfg | 2014-07-24 |
| Catalog Number | DEFDG151 |
| Lot Number | 00266578 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2014-08-21 |