MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-02-18 for METRX SYSTEM 9560702 manufactured by Medtronic Sofamor Danek Instrument Manufacturing.
[1839825]
It was reported that the patient was burned by the coupling between the lightsource and the cable. It is unknown the severity of the burn. However no other patient complications were reported during and after the surgery.
Patient Sequence No: 1, Text Type: D, B5
[8951101]
It is unknown what treatment the patient is received. (b)(4). Device was not returned to the manufacturer for evaluation. We are unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2011-00154 |
| MDR Report Key | 1996515 |
| Report Source | 05,07 |
| Date Received | 2011-02-18 |
| Date of Report | 2011-01-26 |
| Date of Event | 2011-01-21 |
| Date Mfgr Received | 2011-01-26 |
| Date Added to Maude | 2011-02-18 |
| 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 | 2011-02-18 |
| Model Number | NA |
| Catalog Number | 9560702 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK INSTRUMENT MANUFACTURING |
| Manufacturer Address | 2975 BROTHER BLVD. BARTLETT TN 38133 US 38133 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-02-18 |