MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-11-08 for MEDX manufactured by Medx Ocala.
[4016860]
Reporter stated in email to medx on (b)(6) 2013 that the patient was participating in isometric testing 0-48 degrees and complained of immediate discomfort following the first testing angle. Testing ceased and medical review with x-ray suggested muscular injury. Pain worsened in the course of the following days. Ct approx (b)(6) 2013 showed l2 crush fracture (25% with posterior retropulsion). This machine was manufactured in 1997. It was purchased used by the current owner approx 2007.
Patient Sequence No: 1, Text Type: D, B5
[11316391]
This machine was manufactured by medx in 1997. It was purchased as used by the current owner in approx 2007. Reporter stated that the device has been use for 6 years and that 130 patients use the device every week in a clinical setting. The reporter stated that this was the only problem that they had with the device. The manufacturer recommended that the machine be sent back to medx for evaluation, however, the owner has declined. The manufacturer then recommended that the device be taken out of service until they could verify that it was functioning properly. The manufacturer has received no further communication from the reporter at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1051095-2013-00001 |
| MDR Report Key | 3467490 |
| Report Source | 07 |
| Date Received | 2013-11-08 |
| Date of Report | 2013-10-30 |
| Date of Event | 2013-07-08 |
| Date Mfgr Received | 2013-10-09 |
| Device Manufacturer Date | 1997-01-01 |
| Date Added to Maude | 2013-11-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 839 NW 25TH AVE. |
| Manufacturer City | OCALA FL 34475 |
| Manufacturer Country | US |
| Manufacturer Postal | 34475 |
| Manufacturer Phone | 3523512005 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDX |
| Generic Name | LUMBAR EXTENSION MACHINE |
| Product Code | ION |
| Date Received | 2013-11-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDX OCALA |
| Manufacturer Address | FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-11-08 |