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 2019-03-19 for SPATIALFRAME.COM SOFTWARE 71070401 manufactured by Smith & Nephew, Inc..
[139236774]
Patient Sequence No: 1, Text Type: N, H10
[139236775]
It was reported that just prior to the start of the case, surgeon noticed the site just showed a blank screen. The case went ahead but without being able to use the spatial frame software. The problem was rectified and a residual correction was ran at the end of the case. Event did not result in any adverse outcome for the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2019-01103 |
| MDR Report Key | 8433768 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-19 |
| Date of Report | 2019-09-20 |
| Date of Event | 2019-02-25 |
| Date Mfgr Received | 2019-02-25 |
| Date Added to Maude | 2019-03-19 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH AND 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 | 2019-03-19 |
| Catalog Number | 71070401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |