MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-15 for ANATOMAGE GUIDE manufactured by Anatomage Inc..
[175221973]
Based on our investigation, we can conclude that all production processes were properly followed. The fit issue may have been caused by an inaccurate intra-oral scan, which was difficult to detect due to shine present in the patient cbct scan. Doctors are advised not to use the surgical guide for surgery if it does not seat properly as its accuracy may be impacted and may contribute to complications. Sg006 - anatomage guide technical datasheet (rev i) is shipped with every guide and instructs doctors to not use the guide if significant seating issues persist. In this case, the doctor acknowledged that it did not seat well, but chose to proceed with surgery. However, the doctor determined that the surgery was successful, and as a result chose to leave the implant in. This suggests that although the guide was not seated properly, it functioned as intended and no adverse events occurred as a result of using it. Therefore, the exact cause of the implant failure could not be determined. Implants fail for a wide variety of reasons, any of which could have caused the failure in this case.
Patient Sequence No: 1, Text Type: N, H10
[175221975]
The doctor stated that the guide was rocking, mainly on the right side, but proceeded with surgery. After placing the implant at site #7, he determined that surgery was successful and left it in. However, the implant failed an undisclosed amount of time later. Although the surgery occurred on (b)(6) 2019, the issue was not reported to anatomage until (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272529-2019-00032 |
| MDR Report Key | 9593849 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-05-29 |
| Date Mfgr Received | 2019-12-20 |
| Device Manufacturer Date | 2019-05-23 |
| Date Added to Maude | 2020-01-15 |
| 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 95110 |
| Manufacturer Country | US |
| Manufacturer Postal | 95110 |
| Manufacturer G1 | ANATOMAGE INC. |
| Manufacturer Street | 303 ALMADEN BLVD. SUITE 700 |
| Manufacturer City | SAN JOSE CA 95110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95110 |
| 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 | 2020-01-15 |
| 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 95110 US 95110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-15 |