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 37502 manufactured by Dentsply Implants N.v..
[5644812]
As implant surgi-guide was used for planning and placing two (2) implants in the maxilla. After preparing the site for region 15 (#4) the dentist noted a lack of a buccal bone plate. Whereas the other implant in region 13 (#6) was placed successfully, the implant in region 15 (#4) was not inserted as intended, thus the surgical treatment was not completed as planned. This implant is intended to be placed at a later date.
Patient Sequence No: 1, Text Type: D, B5
[13160845]
Therefore, because an additional surgery is required, this event is reportable per 21cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00005 |
| MDR Report Key | 4702907 |
| Report Source | 01,05 |
| Date Received | 2015-04-14 |
| Date of Report | 2014-11-25 |
| Date Mfgr Received | 2014-11-25 |
| Device Manufacturer Date | 2014-08-01 |
| 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 | 37502 |
| 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 |