MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-01 for ANATOMAGE GUIDE manufactured by Anatomage Inc..
[177754074]
Based on our investigation, we can conclude that the drill depth of the surgical guide aligns with that of the final plan used in fabrication, as well as the prescribed drill length. Performing the osteotomy using the required drill length using a properly seated guide should have resulted in the planned depth. The implant may have been placed deeper due to a lack of bone directly below the planned implant's apex, or due to unknown complex clinical aspects.
Patient Sequence No: 1, Text Type: N, H10
[177754075]
The doctor wanted to place a 15 mm implant using a surgical guide, but it was incompatible with the anatomage modeling software. To rectify this, the implant length was changed to the 13 mm implant which is compatible, and shifted apically 2 mm to align with the apex of the 15 mm implant. After placing the implant, the doctor noticed that the implant was ~3 - 4 mm submerged in bone. He then took an x-ray and noticed that the apex was hitting the top of the nerve canal, which was 2 mm deeper than he had planned. He removed the implant and re-positioned it to be a few millimeters short of where it previously was. The patient did not appear to have any nerve damage and the implant was left in.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272529-2020-00001 |
| MDR Report Key | 9656421 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-01 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-11-22 |
| Date Added to Maude | 2020-02-01 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 | 2020-02-01 |
| Returned To Mfg | 2020-01-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-02-01 |