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..
[94143235]
Patient Sequence No: 1, Text Type: N, H10
[94143236]
It was reported the prescription for the distal frame was inverted in the software. The surgeon realized the prescription did not look correct. He logged out and back in and the problem was corrected. There was no effect to the patient.
Patient Sequence No: 1, Text Type: D, B5
[119402632]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2017-01194 |
| MDR Report Key | 7095819 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-07 |
| Date of Report | 2018-01-04 |
| 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 |
| Removal Correction Number | HHE-2017-86-TN |
| 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 | R |
| 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 |