MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-07-17 for INCLUSIVE TAPERED IMPLANT 4710 2000586 manufactured by Prismatik Dentalcraft.
[19106377]
On (b)(6) 2012, dr. (b)(6) reported that the dental implant failed and was subsequently removed. On (b)(6) 2012, three implants were placed in the areas of teeth numbers 19, 29, 30. The procedure was uneventful. On (b)(6) 2012, the pt reported some soreness around tooth number 19 and stated that it had began 5 days earlier. Upon examination, the implant was not mobile, there was no bleeding when probed, and no bone loss noted. The dentist did notice a small apthous fiber ulcer on the pt's tongue. The site was irrigated with peridex and the pt was given an irrigation syringe and peridex for home use. On (b)(6) 2012, the pt returned complaining of swelling upon examination, the dentist noticed mild inflammation around tooth number 19, slight tenderness, and bleeding when probed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005477956-2012-00007 |
| MDR Report Key | 2868174 |
| Report Source | 05 |
| Date Received | 2012-07-17 |
| Date of Report | 2012-07-17 |
| Date of Event | 2012-06-08 |
| Date Mfgr Received | 2012-06-20 |
| Device Manufacturer Date | 2011-07-08 |
| Date Added to Maude | 2012-12-31 |
| 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 | MR BRANDON SHEPARD |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal | 92612 |
| Manufacturer Phone | 9492251243 |
| Manufacturer G1 | PRISMATIK DENTALCRAFT INC. |
| Manufacturer Street | 2212 DUPONT DRIVE SUITE P |
| Manufacturer City | IRVINE CA 92612 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92612 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INCLUSIVE TAPERED IMPLANT |
| Generic Name | DENTAL IMPLANT, PRODUCT CODE: OAT |
| Product Code | OAT |
| Date Received | 2012-07-17 |
| Returned To Mfg | 2012-06-20 |
| Model Number | 4710 |
| Catalog Number | 2000586 |
| Lot Number | 6001382 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRISMATIK DENTALCRAFT |
| Manufacturer Address | 2181 DUPONT DR. SUITE P IRVINE CA 92612 US 92612 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-17 |