MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-06-10 for SURGIGUIDE GUIDE 37504 manufactured by Dentsply Implants N.v..
[5869431]
In this event a dr reported that a surgiguide caused him to improperly place four implants. Two of the implants fenestrated the pt's bone and one implant was placed too buccal in the pt's mouth. All four implants still remain in the pt's mouth. It is unk if any further treatment is planned.
Patient Sequence No: 1, Text Type: D, B5
[13370414]
There has been a previous report received where this malfunction resulted in a serious injury; therefore, it must be presumed that recurrence of this malfunction could possibly cause or contribute to a serious injury or require med or surgical intervention to preclude such. As such this event is reportable per 21 cfr part 803. The dr refused to return the device for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00008 |
| MDR Report Key | 4841644 |
| Report Source | 05 |
| Date Received | 2015-06-10 |
| Date of Report | 2015-05-13 |
| Date Mfgr Received | 2015-05-13 |
| Device Manufacturer Date | 2015-04-21 |
| Date Added to Maude | 2015-06-15 |
| 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 | SUSQUEHANNA COMMERCE CTR W 221 W PHILADELPHIA ST STE 60 |
| 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 |
| Product Code | EBG |
| Date Received | 2015-06-10 |
| Catalog Number | 37504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2015-06-10 |