MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-12-19 for UTILITY PLIER (WEINGART STYLE) ODG-0158 manufactured by Dentsply Gac.
[19017299]
In this event it was reported that the tip of a utility plier (weingart style) separated inside of a patient's mouth and chipped their tooth. As a result a composite crown was placed.
Patient Sequence No: 1, Text Type: D, B5
[19215453]
Because evaluation of the unit involved is not complete as of this report and since this issue could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, it must be presumed that the device malfunctioned and that the malfunction would be likely to cause/contribute to a serious injury should it recur. As such, this event meets the criteria for reportability per 21 cfr part 803. The device was found to be within specification. During the investigation it was found that the doctor was using utility pliers as a crimpable stop, which is not the intended use of this device, and likely the cause for the beak breakage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2086211-2012-00001 |
| MDR Report Key | 2887392 |
| Report Source | 05 |
| Date Received | 2012-12-19 |
| Date of Report | 2012-11-26 |
| Date of Event | 2012-11-19 |
| Date Mfgr Received | 2012-11-26 |
| Date Added to Maude | 2012-12-28 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 221 W PHILADELPHIA ST, STE 60 SUSQUEHANNA COMMERCE CENTER W |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | ORTHODENTAL INTL., INC. |
| Manufacturer Street | 2306 M.L. KING, SUITE 1 |
| Manufacturer City | CALEXICO CA 92231 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92231 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UTILITY PLIER (WEINGART STYLE) |
| Product Code | JEX |
| Date Received | 2012-12-19 |
| Returned To Mfg | 2012-12-13 |
| Catalog Number | ODG-0158 |
| Lot Number | 07-06-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY GAC |
| Manufacturer Address | BOHEMIA NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-12-19 |