MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-07-29 for SURGIGUIDE GUIDE 37504 manufactured by Dentsply Implants N.v..
[15139845]
It was reported that a surgiguide was used to place four implants (regions not indicated). The implants were placed too shallow and had to be removed.
Patient Sequence No: 1, Text Type: D, B5
[15377797]
According to the available information, the dentist changed the final design of the guide on the cast model to modify the position of the planned implant in region 34. In addition, it is stated that he did not use the drills as advised to enlarge the apical part of the osteotomy, in order to adapt the design of the site to the local bone quality: in the mandible usually the predominant bone quality is of dense type, thus the enlargement of the prepared bone is required to limit the insertion torque to sufficient values. The fact that the implants were not placed into the final position, e. G. As deep as intended, seems to be a sign for an incomplete preparation of the implant site. Therefore, because surgery could not be completed as intended, this event is reportable per 21 cfr part 803. It's clear the changes in the mouth after impression was made caused the bad fit and the bad transfer. The dentist realized and corrected his own mistake and was able to complete the surgery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00011 |
| MDR Report Key | 4961253 |
| Report Source | 01,05 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-04-22 |
| Date Mfgr Received | 2015-04-22 |
| Date Added to Maude | 2015-08-04 |
| 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 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 | 2015-07-29 |
| Catalog Number | 37504 |
| Lot Number | NA |
| 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. Required No Informationntervention | 2015-07-29 |