MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2015-03-06 for SURGIGUIDE GUIDE 37504 manufactured by Dentsply Implants N.v..
[5447443]
According to available information, a simplant surgiguide was used for planning and placing four (4) implants in the mandible of a patient. The preparation of the implant bed for 3 implants was successfully performed, while a fenestration of the lingual bone plate occurred when preparing the osteotomy for the implant in region 44. The investigation of the returned guide revealed that it was mirroring the situation as planned with the simplant software and provided the same position on the bone model as in the planning. The implant in region 44 was not placed and the surgical treatment was not completed as indicated.
Patient Sequence No: 1, Text Type: D, B5
[12987848]
Therefore, because surgery could not be completed, this event is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00001 |
| MDR Report Key | 4585146 |
| Report Source | 01,05 |
| Date Received | 2015-03-06 |
| Date of Report | 2014-12-04 |
| Date Mfgr Received | 2014-12-04 |
| Device Manufacturer Date | 2014-11-01 |
| Date Added to Maude | 2015-03-11 |
| 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 | 2015-03-06 |
| Returned To Mfg | 2014-12-11 |
| Catalog Number | 37504 |
| 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. Required No Informationntervention | 2015-03-06 |