MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-29 for ANATOMAGE GUIDE manufactured by Anatomage Inc..
[188815212]
Based on our investigation, we can conclude that an error during software phase 2 caused an unapproved final plan to be used in production. This caused the sleeve to be placed slightly more distal than originally planned (but still within the standard deviation range). However, since the doctor reported that the implant was extremely more distal than he had planned, it's possible that the issue was exaggerated due to the planned trajectory being misperceived during the doctor's planning. All responsible technicians have been made aware of the issue and understand how to prevent it in the future.
Patient Sequence No: 1, Text Type: N, H10
[188815213]
After using the guide to place the implant at site #11, the doctor took an x-ray of the patient. From this x-ray, he determined that the implant was more distal than he had planned. He then removed the implant, free-handed drilling, and re-placed the implant. Surgery for implant #11 was successful, but implant #14 was not placed as planned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008272529-2019-00033 |
| MDR Report Key | 9644020 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-29 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2019-12-13 |
| Date Added to Maude | 2020-01-29 |
| 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 | 2020-01-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2020-01-29 |