MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-07 for SPATIALFRAME.COM SOFTWARE 71070401 manufactured by Smith & Nephew, Inc..
[94143250]
Patient Sequence No: 1, Text Type: N, H10
[94143271]
It was reported after entering all parameters for the case, it was noticed that the software constructed the distal frame in an inverted fashion. The surgeon logged out of the software and logged back in and the issue was resolved. The issue had no affect on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2017-01197 |
| MDR Report Key | 7095814 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-07 |
| Date of Report | 2018-01-18 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-12-07 |
| 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 | MARKUS POETTKER |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPATIALFRAME.COM SOFTWARE |
| Generic Name | SOFTWARE FOR DIAGNOSIS/TREATMENT |
| Product Code | OSN |
| Date Received | 2017-12-07 |
| Catalog Number | 71070401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-07 |