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 2018-08-09 for SPATIALFRAME.COM SOFTWARE 71070401 manufactured by Smith & Nephew, Inc..
[116604964]
Patient Sequence No: 1, Text Type: N, H10
[116604965]
It was reported that the surgeon was performing a femoral chaos which needed access to the tsf website intraoperatively. When the surgeon went to access the website he could enter details up to stage 5 then the programme would not respond. The surgeon had to complete the frame and then wake up the patient and schedule the completion of the case for the next day.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2018-01499 |
| MDR Report Key | 7768370 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-09 |
| Date of Report | 2019-01-14 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-07-17 |
| Date Added to Maude | 2018-08-09 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD HULL |
| Manufacturer City | HULL, HU32BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU32BN |
| 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 | 2018-08-09 |
| Catalog Number | 71070401 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| 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 | 1. Hospitalization | 2018-08-09 |