MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2015-08-06 for SURGIGUIDE GUIDE 37506 manufactured by Dentsply Implants N.v..
[22727701]
Therefore, because this event resulted in a serious injury, it is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[22727702]
It was reported that a surgiguide did not match the patient's procedure. Implant placement was only possible for 1 of 6 planned implants. During preparation of the one implant, the drill penetrated the patient's sinus membrane.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007362683-2015-00013 |
| MDR Report Key | 4990638 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-08-06 |
| Date of Report | 2014-12-12 |
| Date Mfgr Received | 2014-12-12 |
| 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 | SUSQUEHANNA COMMERCE CENTER W. 221 W. PHILADELPHIA ST., STE. 60 |
| Manufacturer City | YORK PA 174010000 |
| Manufacturer Country | US |
| Manufacturer Postal | 174010000 |
| 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 | 2015-08-06 |
| Catalog Number | 37506 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DENTSPLY IMPLANTS N.V. |
| Manufacturer Address | HASSELT BE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-08-06 |