MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-17 for ANATOMAGE GUIDE manufactured by Anatomage Inc..
[188815799]
Based on our investigation, the guide mold's trajectory aligns with the treatment plan, and no issues were noted during the guide's fabrication. Additionally, all production processes were found to have been properly followed. The cause of the trajectory deviation could not be determined. Further testing will be conducted if the surgical guide is returned.
Patient Sequence No: 1, Text Type: N, H10
[188815800]
The doctor used the guide for implant surgery. The drill penetrated the patient's lingual plate at site #8. Site #8 was grafted and sutured. Implant #9 was placed successfully. The incident occurred on (b)(6) 2019; however, the doctor did not report it to anatomage until (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272529-2020-00003 |
| MDR Report Key | 9838742 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-12-28 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-12-19 |
| Date Added to Maude | 2020-03-17 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MEERA KLER |
| Manufacturer Street | 303 ALMADEN BLVD. SUITE 700 |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer G1 | ANATOMAGE INC. |
| Manufacturer Street | 303 ALMADEN BLVD. SUITE 700 |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANATOMAGE GUIDE |
| Generic Name | SURGICAL GUIDE |
| Product Code | NDP |
| Date Received | 2020-03-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANATOMAGE INC. |
| Manufacturer Address | 303 ALMADEN BLVD. SUITE 700 SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |