MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05 report with the FDA on 2015-04-01 for SURGIGUIDE GUIDE 37504 manufactured by Dentsply Implants N.v..
[5683986]
A simplant surgiguide was used to place four implants in the mandible. The implant in region 35 (# 20) was not covered with bone lingually when placed into final position. Thus the dentist removed it and replaced it in the same session with an implant in region 36 (#19) instead, without using a guide.
Patient Sequence No: 1, Text Type: D, B5
[13036626]
This event required intervention and therefore meets the criteria for reportability per 21 cfr part 803. The device was not returned for eval and the lot number was not provided for retained-product testing and/or dhr review.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00002 |
| MDR Report Key | 4658444 |
| Report Source | 01,02,05 |
| Date Received | 2015-04-01 |
| Date of Report | 2015-03-03 |
| Date of Event | 2015-02-09 |
| Date Mfgr Received | 2015-03-03 |
| Device Manufacturer Date | 2014-12-01 |
| Date Added to Maude | 2015-04-06 |
| 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 | 2015-04-01 |
| Catalog Number | 37504 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-04-01 |