MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-11 for ANATOMAGE GUIDE manufactured by Anatomage Inc..
[188815320]
Based on our investigation, we can conclude that the trajectory of the guide aligns with the final plan. The doctor's planned implant proximity to the lingual plate likely contributed to its perforation, potentially in addition to excessive lateral force being applied during surgery, and/or other unknown complex clinical aspects.
Patient Sequence No: 1, Text Type: N, H10
[188815321]
The doctor received two guides to be used for implant placement on a patient's maxilla and mandible arches. For the maxilla, all implants were placed successfully. For the mandible, #30 was placed successfully, but #19 drilled through the lingual plate. The doctor stated that when drilling #19, she felt resistance. However, due to the guide covering the soft tissue, she could not see the lingual plate being perforated. After removing the guide, she saw the perforation, and stated that the bone looked like "sawdust". The implant was then removed, and the area was grafted. The doctor also stated that since a guide that she ordered from us previously was "perfect", she did not question this guide, even when the drilling felt "weird" and the trajectory looked lingual. 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 | 3008272529-2020-00002 |
| MDR Report Key | 9696038 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2019-09-17 |
| Date Mfgr Received | 2020-01-23 |
| Device Manufacturer Date | 2019-09-12 |
| Date Added to Maude | 2020-02-11 |
| 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 | 2020-02-11 |
| Returned To Mfg | 2020-02-05 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-11 |