MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-08-06 for SURGIGUIDE GUIDE 37502 manufactured by Dentsply Implants N.v..
[22640731]
Because surgery could not be completed, this event is reportable per 21 cfr part 803. We checked the design and found no points of particular concern. The fracture probably was caused by a combination of a particularly large opening due to the neighboring tooth and an excessive force applied during surgery.
Patient Sequence No: 1, Text Type: N, H10
[22640732]
A dentist reported the fracture of a surgiguide during surgery. The surgiguide was being used to support the placement of two implants in the mandible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007362683-2015-00015 |
| MDR Report Key | 4990628 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-08-06 |
| Date of Report | 2015-03-30 |
| Date Mfgr Received | 2015-03-30 |
| Device Manufacturer Date | 2015-01-20 |
| Date Added to Maude | 2015-08-11 |
| 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 | 3 |
| Event Location | 3 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGIGUIDE GUIDE |
| Generic Name | VARIOUS, EBG, LLZ, DZE |
| Product Code | EBG |
| Date Received | 2015-08-06 |
| Returned To Mfg | 2015-03-27 |
| Catalog Number | 37502 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2015-08-06 |