MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-04-14 for SURGIGUIDE GUIDE 37503 manufactured by Dentsply Implants N.v..
[5644315]
It was reported that a simplant guide was used for planning and placing three implants in the mandible. When preparing the implant site in region 45 (# 29) the drill hit the adjacent tooth (region 44/ #28). The doctor stated the longstop drill had too much space in the guide.
Patient Sequence No: 1, Text Type: D, B5
[13160842]
The investigation of the returned guide and related accessories revealed no flaws in producing the guide, neither by using the wrong tubes nor presenting too high tolerances or an inaccurately manufactured guide. However, because a serious injury occurred, this event is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00004 |
| MDR Report Key | 4702901 |
| Report Source | 01,05 |
| Date Received | 2015-04-14 |
| Date of Report | 2014-11-14 |
| Date Mfgr Received | 2014-11-14 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-04-20 |
| 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 |
| Generic Name | VARIOUS |
| Product Code | EBG |
| Date Received | 2015-04-14 |
| Returned To Mfg | 2014-12-03 |
| Catalog Number | 37503 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2015-04-14 |