MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,user facility report with the FDA on 2012-11-29 for MAST QUADRANT RETRACTOR SYSTEM 9560658 manufactured by Warsaw Orthopedics.
[3045339]
It was reproted that a patient with lumbar spinal stenosis was undergoing a laminectomy at l4-5. It was reported that the patient was in the prone position and the illumination system was attached to the standard or light source. During the procedure, the device was found to be very hot at the connection from the retractor connection to the light cord. The device was immediately taken out of service and the patient was immediately assessed and not injury identified. At the time of closure, an area of redness with one small blister was noted on the patient's right upper back. No additional complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[10341093]
(b)(6). (b)(4). Neither the device nor applicable imaging films were returned to the manufacturer for evaluation; therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2012-02473 |
| MDR Report Key | 2850275 |
| Report Source | 06,USER FACILITY |
| Date Received | 2012-11-29 |
| Date of Report | 2012-11-02 |
| Date of Event | 2012-09-18 |
| Date Mfgr Received | 2012-11-02 |
| Device Manufacturer Date | 2012-04-03 |
| Date Added to Maude | 2012-11-29 |
| 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 | HUZEFA MAMOOLA |
| 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 | MAST QUADRANT RETRACTOR SYSTEM |
| Generic Name | TAPE, MEASURING, RULERS AND CALIPERS |
| Product Code | FTY |
| Date Received | 2012-11-29 |
| Model Number | NA |
| Catalog Number | 9560658 |
| Lot Number | 0203995W |
| 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 ORTHOPEDICS |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-29 |