MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-07-27 for MAST QUADRANT RETRACTOR SYSTEM 9560658 manufactured by Warsaw Orthopedics.
[20151988]
It was reported that, intra-op, a burn was noticed after the field was broken down. Some portion of the retractor lighting system caused the issue. The product contact with the patient is unknown. The patient is alive with injury(burn).
Patient Sequence No: 1, Text Type: D, B5
[20471015]
(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
[31718745]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
[31718746]
The product came in contact with the patient.
Patient Sequence No: 1, Text Type: D, B5
[36736053]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[36736054]
As per voluntary medwatch form, patient had low back pain and bilateral extremity pain and numbness. Patient had been experiencing progressively worsening symptoms despite non-operative management. Patient consented to surgical treatment. Patient status post left l3-4 direct lateral interbody fusion with posterior instrumentation in 2015. When drapes were removed, the patinet was found to have a left flank "burn" of 7x2. 5 cm of non-blanchable erythema with a fluid filled blister in the center measuring 3. 5 cm x 1. 5 cm. There was no evidence to the alteration to the sterile drapes (i. E. Burn mark). This discovered event was discussed/examined by the surgical team, anesthetic team and the circulating nurse. The surgical team discussed the possibility of the burn occurring from the light cord connection to the fiberoptic cable and all components were collected/delivered to the operating room manager for full investigation. The burn area was covered with a sterile dressing and a wound care specialist was consulted. Post-op the left flank wound was clean and healing aptly. Patient was followed closely by the wound consult service. The spine service checked wound at discharge and patient was to follow up in 2 weeks. Patient's spine surgeon spoke to dermatologist and ordered silver sulfadiazine 1% cream application with tape twice daily and instructed to cover with dressing. Patient discharged home with home services for dressing changes and wound monitoring. Upon follow up visit with the spine surgeon it was discovered that the burn had increased to a serious reportable event requiring a change in the treatment plan with question debridement of wound and increased dressing changes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030489-2015-01672 |
| MDR Report Key | 4941733 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-07-27 |
| Date of Report | 2015-10-27 |
| Date of Event | 2015-06-30 |
| Date Mfgr Received | 2015-10-27 |
| Device Manufacturer Date | 2015-02-10 |
| Date Added to Maude | 2015-07-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG ANGLIN |
| 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 | LIGHT, SURGICAL, CARRIER |
| Product Code | FSZ |
| Date Received | 2015-07-27 |
| Model Number | NA |
| Catalog Number | 9560658 |
| Lot Number | 0362288W |
| 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 | 2015-07-27 |