MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-05-20 for LONG HANDLE WEINGART PLIERS 866-2013 manufactured by Ormco Corporation.
[145547134]
On (b)(6) 2019, during a routine activation appointment while crimping the stops on a maxillary 19x25tma archwire, the beak of an ormco weinghart plier broke intra-orally. This resulted in a slip and fracture of the mesial incisal corner of the patient's #21 as well as a small laceration of the attached gingival apical to the #21 and a small cut in the maxillary lip near the vermillion border. The patient required a composite restoration on the #21 which was completed by the family dentist 48 hours later. Future restorative needs for the #21 are undetermined at this time, however, it is likely that the patient will require future prosthodontic treatment with either a porcelain veneer or a full coverage crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2016150-2019-00012 |
| MDR Report Key | 8625181 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-05-20 |
| Date of Report | 2019-05-20 |
| Date of Event | 2019-03-29 |
| Date Mfgr Received | 2019-04-23 |
| Date Added to Maude | 2019-05-20 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUZETTE RAMPAIR-JOHNSON |
| Manufacturer Street | 18889 WEST MISSION BLVD. |
| Manufacturer City | POMONA CA 91766 |
| Manufacturer Country | US |
| Manufacturer Postal | 91766 |
| Manufacturer Phone | 9096713434 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1889 WEST MISSION BLVD. |
| Manufacturer City | POMONA CA 91766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LONG HANDLE WEINGART PLIERS |
| Generic Name | EYJ |
| Product Code | EJY |
| Date Received | 2019-05-20 |
| Catalog Number | 866-2013 |
| Lot Number | C18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1889 WEST MISSION BLVD. POMONA CA 91766 US 91766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-20 |