MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-06 for INFUSE * manufactured by Medtronic.
[2022379]
Patient underwent cervical vertebra (c3-c7) posterior cervical decompression, posterior cervical fusion and instrumentation. Utilization of bone morphogenic protein (bmp). Post-operative neck swelling was observed. During extubation attempt, pt self extubated and clinicians were unable to reintubate despite multiple tries requiring tracheostomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2088030 |
| MDR Report Key | 2088030 |
| Date Received | 2011-05-06 |
| Date of Report | 2011-05-06 |
| Date of Event | 2011-04-29 |
| Report Date | 2011-05-06 |
| Date Reported to FDA | 2011-05-06 |
| Date Added to Maude | 2011-05-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE MORPHOGENIC PROTEIN |
| Product Code | MPW |
| Date Received | 2011-05-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC |
| Manufacturer Address | 4340 SWINNEA RD. MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-05-06 |