MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-24 for SURGIGUIDE GUIDE 37502 manufactured by Dentsply Implants N.v..
[5261046]
In this event it was reported that simplant guides were used to carry out an implant surgery. The first guide was placed into the mouth of the patient and the first drill steps were performed, while the assistant held the guide in place by applying pressure onto the anterior teeth. After removing the first guide and placing the drills in the osteotomies the dentist realized that they were canted mesially, and when positioning the second guide a distinct rocking motion antero-posteriorly was noted. This rocking motion was present for all 3 guides. Thus the dentist decided to stop the procedure since he was uncertain about the correct implant transfer.
Patient Sequence No: 1, Text Type: D, B5
[12608639]
All three (3) guides and the plaster model were investigated by the simplant team. The testing of these guides on the plaster model revealed a distinct rocking motion when applying pressure to either the anterior teeth or to the posterior molar (#30). When no pressure is applied the fit of the guide was good and it was in the correct position. It is recommended to avoid any incorrect fitting clinically to mimic the situation on the plaster model before using the guide. Although the patient was not harmed the surgical intervention was not completed as intended due to malfunction of the product. As such, this event is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2014-00001 |
| MDR Report Key | 4374842 |
| Report Source | 05 |
| Date Received | 2014-12-24 |
| Date of Report | 2014-08-06 |
| Date Mfgr Received | 2014-08-06 |
| Date Added to Maude | 2015-01-02 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HELEN LEWIS |
| Manufacturer Street | 2221 W. PHILADELPHIA ST. STE. 60 SUSQUEHANNA COMMERCE CENTER W. |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIGUIDE GUIDE |
| Generic Name | VARIOUS |
| Product Code | EBG |
| Date Received | 2014-12-24 |
| Returned To Mfg | 2014-08-11 |
| Catalog Number | 37502 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY IMPLANTS N.V. |
| Manufacturer Address | HASSELT, LIMBURG BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-24 |