MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for NAVIO SURGICAL SYSTEM AU NPFS02070 manufactured by Blue Belt Technologies.
[185637936]
It was reported that during surgery the patient was a large male patient and would have ideally have suited a size 9 femoral prosthesis, however software does not support a size 9 implant. Smaller prosthesis was implanted (size 8) and more bone was resected posteriorly and distally to balance the knee. The femoral flexion was increased to 6.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010266064-2020-00096 |
| MDR Report Key | 9874455 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-24 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RICK CONFER |
| Manufacturer Street | 2828 LIBERTY AVE SUITE 100 |
| Manufacturer City | PITTSBURGH PA |
| Manufacturer Country | US |
| Manufacturer G1 | BLUE BELT TECHNOLOGIES |
| Manufacturer Street | 2905 NORTHWEST BLVD STE 40 |
| Manufacturer City | PLYMOUTH MN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVIO SURGICAL SYSTEM AU |
| Generic Name | ORTHOPEDIC STEREOTAXIC INSTRUMENT |
| Product Code | OLO |
| Date Received | 2020-03-24 |
| Catalog Number | NPFS02070 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BLUE BELT TECHNOLOGIES |
| Manufacturer Address | 2905 NORTHWEST BLVD STE 40 PLYMOUTH MN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-24 |