MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-13 for NAVIGATOR GUIDE manufactured by Materialise Dental Nv.
[2001861]
In this event, it was reported that a doctor hit a nerve during a placement of several implants using a surgical guide. As a result, the patient experienced numbness on the left side of the chin to the left mental foramen and lip.
Patient Sequence No: 1, Text Type: D, B5
[9056429]
While the device involved in this event did not malfunction, because of the possibility that medical/surgical intervention may be required and/or permanent impairment may result, this event meets the criteria for reportability per 21 cfr part 803. Investigation shows that the surgical guide was manufactured in accordance with the doctor's planning.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3006638827-2011-00001 |
| MDR Report Key | 2098841 |
| Report Source | 05 |
| Date Received | 2011-05-13 |
| Date of Report | 2011-04-14 |
| Date of Event | 2011-04-06 |
| Date Mfgr Received | 2011-04-14 |
| Device Manufacturer Date | 2010-12-17 |
| Date Added to Maude | 2011-05-26 |
| 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 CENTER W 221W PHILADELPHIA ST., STE 60 |
| Manufacturer City | YORK PA 17401 |
| Manufacturer Country | US |
| Manufacturer Postal | 17401 |
| Manufacturer Phone | 7178457511 |
| Manufacturer G1 | MATERIALISE DENTAL NV |
| Manufacturer Street | TECHNOLOGIELAAN 15 |
| Manufacturer City | LEUVEN 3001 |
| Manufacturer Country | BE |
| Manufacturer Postal Code | 3001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIGATOR GUIDE |
| Product Code | KMY |
| Date Received | 2011-05-13 |
| Model Number | NAVIGATOR GUIDE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATERIALISE DENTAL NV |
| Manufacturer Address | TECHNOLOGIELAAN 15 LEUVEN 3001 BE 3001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-13 |