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 37508 manufactured by Dentsply Implants N.v..
[5286947]
In this event it was reported that a simplant guide was used to carry out an implant surgery. The guide was placed into the oral cavity and although it was misaligned it fit, thus the dentist prepared the osteotomies and it turned out that all implants on the left side were fenestrating the buccal bone plate.
Patient Sequence No: 1, Text Type: D, B5
[12632643]
The investigation by the simplant team showed that "the prosthesis information could not easily be matched into the scan images because the dual scan protocol was not followed correctly. The implants in region 4, 5, and 6 were planned relatively close to the cortical bone," which need to be avoided by all means to not compromise the integrity of the bone plate. In addition it turned out that the scan parameters were insufficient, the accuracy of the scan was only 0. 18mm into the bone (such as implants 4 and 7) have no certainty of being actually in the bone surface in real life. It can be concluded that the customer did some mistakes in planning the case properly, but these flaws should have been detected by the simplant team and in consequence the dentist needs to be informed that no guarantees could be made about the transfer of the implants. Hence user is able to assess whether he or she wants to proceed under those circumstances. Due to an error this notification was not sent. The team embers in question have been informed of this particular issue and will receive additional training. However, it is recommended to keep the commonly accepted distances to important anatomical areas, i. E. Bone plates and adjacent teeth, and to use the "fenestration" function when planning cases which make potentially affected areas visible. The buccal bone plate was destroyed which required additional steps to solve this issue and the quality management did not work properly.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2014-00002 |
| MDR Report Key | 4374841 |
| Report Source | 05 |
| Date Received | 2014-12-24 |
| Date of Report | 2014-09-16 |
| Date Mfgr Received | 2014-09-16 |
| 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 | 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 |
| Product Code | EBG |
| Date Received | 2014-12-24 |
| Returned To Mfg | 2014-09-15 |
| Catalog Number | 37508 |
| 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. Other | 2014-12-24 |