MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-29 for SURGIGUIDE GUIDE 37506 manufactured by Dentsply Implants N.v..
[6254600]
In this case, a customer intended to place competitor implants (biohorizon) by using a surgiguide, subsequently after extensively reducing the local bone supported by a simplant reduction guide. However, he was not able to seat the drill guide properly, thus he assumed that the bone was not reduced sufficiently and removed more bone material from the mandible. But still the drill guide did not fit as desired and he suspected that the drills were not able to go deep enough into the bone. He assumed that the guiding tubes were located too high in the guide.
Patient Sequence No: 1, Text Type: D, B5
[14087530]
The internal inspection revealed that the bone reduction was too voluminous, thus the improper fit of the surgical guide occurred. Therefore, because treatment could not be completed, this event is reportable per 21 cfr part 803. The bad fit of the drill guide is probably caused by the complexity of the reduced area. It would be unlikely that the bone edge during surgery was obtained in the same way as the digital simulation thereof. A replacement order after a new scan will be taken.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00012 |
| MDR Report Key | 4961237 |
| Report Source | 05 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-05-22 |
| Date Mfgr Received | 2015-05-22 |
| Device Manufacturer Date | 2015-05-15 |
| 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 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, EBG, LLZ, DZE |
| Product Code | EBG |
| Date Received | 2015-07-29 |
| Catalog Number | 37506 |
| 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 |