MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-11-15 for UNK - EXFIX manufactured by Synthes (usa).
[2461160]
A mri technician from hospital account reported a (b)(6) old male patient status post ex-fix implantation on an unknown date was scheduled for a mri scan consisting of seven scans. A phased array body coil was used around the knee for the scan. The ex-fix frame was totally wrapped in gauze and the pins were close to, but not touching the side of the coil. During the first scan patient experienced severe pain from the knee to the ankle. The first scan was completed in four and one half minutes. After the scan was completed the pain went away immediately. Technician aborted the remaining six scans. Mri safe documentation for fixators had been sent to the technician in november 2010 by synthes and there were no problems with external fixator scans until this patient.
Patient Sequence No: 1, Text Type: D, B5
[9575557]
Without a lot number the device history review could not be completed. The investigation could not be completed, no conclusion could be drawn as no product was returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2011-00691 |
| MDR Report Key | 2380955 |
| Report Source | 05,07 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-10-18 |
| Date Mfgr Received | 2011-10-18 |
| Date Added to Maude | 2012-02-22 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | S LAING |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | EFIX |
| Product Code | KRS |
| Date Received | 2011-11-15 |
| Catalog Number | UNK - EXFIX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | WEST CHESTER PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |