MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-05-27 for METRX SYSTEM 9560702 manufactured by Warsaw Orthopedic, Inc..
[2145392]
It was reported that the patient underwent a mini-invasive spinal procedure. The patient had a rectangular burn on his back intraope ratively where the light box cable meets the light source. It was discovered immediately after surgery. The burn was about an inch and a half around. The hospital confirms that the light source was used with a light box setting on around 300 watts. The hospital stated that the staff was not aware of the warning label on the product packaging that references using a 100 watt light source. Reportedly, the patient was treated at the office and given a cream. No other patient complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[9022053]
(b)(4). Device was not returned to the manufacturer for evaluation. We are unable to determine the cause of the event. A review of device history records is not possible at this time without additional device information.
Patient Sequence No: 1, Text Type: N, H10
[9127327]
Device history records were reviewed. No documentation was found that would indicate a non-conformance to specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2011-00628 |
| MDR Report Key | 2105058 |
| Report Source | 05,07 |
| Date Received | 2011-05-27 |
| Date of Report | 2011-04-13 |
| Date of Event | 2011-04-13 |
| Date Mfgr Received | 2011-05-17 |
| Device Manufacturer Date | 2011-02-23 |
| Date Added to Maude | 2011-05-27 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHAD ASHTON |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | METRX SYSTEM |
| Generic Name | LIGHT, SURGICAL, CARRIER |
| Product Code | FSZ |
| Date Received | 2011-05-27 |
| Model Number | NA |
| Catalog Number | 9560702 |
| Lot Number | 0135693W |
| Device Expiration Date | 2016-01-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WARSAW ORTHOPEDIC, INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-27 |