MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-20 for SPATIALFRAME.COM SOFTWARE 71070401 manufactured by Smith & Nephew, Inc..
[89913754]
Patient Sequence No: 1, Text Type: N, H10
[89913755]
It was reported that a patient had a revision surgery because the software print out incorrect schematic, therefore, the patient preconsolidated at the osteotomy site and required a re-osteotomy.
Patient Sequence No: 1, Text Type: D, B5
[108382655]
This complaint is in regards software error and no device was required to be evaluated. Attached are the investigation results (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2017-00894 |
| MDR Report Key | 6967110 |
| Date Received | 2017-10-20 |
| Date of Report | 2018-01-15 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-09-26 |
| Date Added to Maude | 2017-10-20 |
| 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 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 | 0 |
| Brand Name | SPATIALFRAME.COM SOFTWARE |
| Generic Name | SOFTWARE FOR DIAGNOSIS/TREATMENT |
| Product Code | OSN |
| Date Received | 2017-10-20 |
| Catalog Number | 71070401 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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; 2. Required No Informationntervention | 2017-10-20 |