MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-11 for MAST QUADRANT RETRACTOR SYSTEM 00 MLX 401327T manufactured by Medtronic.
[23403259]
Pt is a (b)(6) male with the low back pain and bilateral extremity pain and numbness. Pt had been experiencing progressively worsening symptoms despite non-operative management. Pt consented to surgical treatment. Pt status post left l3-4 direct lateral interbody fusion with posterior instrumentation on (b)(6) 2015; after surgery, when drapes were removed, the pt was found to have a left flank "burn" of 7 x 2. 5 cm non-blanchable erythema with a fluid filled blister in the center measuring 3. 5cm x 1. 5 cm. There was no evidence of any 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 by the clinical engineering department. The burn area was covered with a sterile dressing and a wound care specialist was consulted. Postoperatively the left flank wound was clean and healing appropriately. Pt was followed closely by the wound consult service. The spine service checked wound at discharge and pt was to f/u in two weeks. Pt's spine surgeon spoke to dermatologist and ordered silver sulfadiazine 1% cream application with tape twice daily and instructed to cover with dressing. Pt discharged home with home (b)(6) services for dressing changes and wound monitoring. Upon f/u visit with the spine surgeon on (b)(6) 2015, 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. Reason for use: visualization of deep incision with lighted retractor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5055393 |
| MDR Report Key | 5006639 |
| Date Received | 2015-08-11 |
| Date of Report | 2015-08-11 |
| Date of Event | 2015-06-30 |
| Date Added to Maude | 2015-08-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAST QUADRANT RETRACTOR SYSTEM |
| Generic Name | MAST QUADRANT RETRACTOR SYSTEM |
| Product Code | FSZ |
| Date Received | 2015-08-11 |
| Model Number | 00 MLX |
| Catalog Number | 401327T |
| Lot Number | 0362288W |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Brand Name | MLX LIGHT SOURCE |
| Generic Name | MLX LIGHT SOURCE |
| Product Code | FCW |
| Date Received | 2015-08-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LUXTEC |
| Brand Name | MAST QUADRANT RETRACTOR / ILLUMINATION SYSTEM |
| Generic Name | MAST QUADRANT RETRACTOR / ILLUMINATION SYSTEM |
| Product Code | FSZ |
| Date Received | 2015-08-11 |
| Catalog Number | 9560658 |
| Lot Number | 0362288W |
| Device Expiration Date | 2015-02-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Address | MEMPHIS TN 38132 US 38132 |
| Brand Name | STRYKER FO CABLE 5M |
| Generic Name | STRYKER FO CABLE 5M |
| Product Code | GEI |
| Date Received | 2015-08-11 |
| Model Number | 233-050-064 |
| Lot Number | 102775 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Brand Name | MEDTRONIC LATERAL RETRACTOR ASSY. |
| Generic Name | MEDTRONIC LATERAL RETRACTOR ASSY. |
| Product Code | GAD |
| Date Received | 2015-08-11 |
| Lot Number | DC07A008 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Brand Name | MEDTRONIC LATERAL RETRACTOR ASSY. |
| Generic Name | MEDTRONIC LATERAL RETRACTOR ASSY. |
| Product Code | GAD |
| Date Received | 2015-08-11 |
| Lot Number | FA09C044 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 6 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Brand Name | MEDTRONIC LATERAL RETRACTOR ASSY. |
| Generic Name | MEDTRONIC LATERAL RETRACTOR ASSY. |
| Product Code | GAD |
| Date Received | 2015-08-11 |
| Lot Number | FA13E015 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 7 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Brand Name | STRYKER LIGHT CABLE |
| Generic Name | STRYKER LIGHT CABLE |
| Product Code | FST |
| Date Received | 2015-08-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 8 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Brand Name | MEDTRONIC DISPOSABLE FO CABLE |
| Generic Name | DISPOSABLE FO CABLE |
| Product Code | GEI |
| Date Received | 2015-08-11 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 9 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-08-11 |