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 37503 manufactured by Dentsply Implants N.v..
[6255991]
It was reported that while using a surgiguide to place three implants, the model initially sat fine in the patient's mouth. At the halfway point of drilling to place implant (b)(4), the guide began to rock and the doctor thought that it was bent. At this point implant (b)(4) was partially placed. The doctor trephined out implant (b)(4) because the implant wasn't in the planned position. The guide was removed and implant (b)(4) was not placed.
Patient Sequence No: 1, Text Type: D, B5
[14305592]
Therefore, because an intervention was required, this event is reportable per 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007362683-2015-00009 |
| MDR Report Key | 4961251 |
| Report Source | 05 |
| Date Received | 2015-07-29 |
| Date of Report | 2015-03-25 |
| Date Mfgr Received | 2015-03-25 |
| Device Manufacturer Date | 2015-02-11 |
| 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 |
| Returned To Mfg | 2015-03-25 |
| Catalog Number | 37503 |
| 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 | 2015-07-29 |