MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2010-09-07 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[21682586]
It is reported the pt presented to the emergency room in moderate distress with neck anterior neck swelling and difficulty swallowing. The pt was 5 days status-post anterior cervical discectomy and fusion (acdf) at c3-c4 and c4-c5 with fixation at c3 to c5, augmented by rh-bmp-2/acs placed inside bioabsorbable interbody grafts. It is noted that a rigid cervical collar was worn continuously for the five days post surgery. There was no wound dehiscence or erythema. Massive neck swelling and small fluid collection was evident ipsilateral to the side of the surgical approach. Radiographs and computed tomographic scan showed several pockets of air within the soft tissues. A discrete hematoma was not present. There were no signs of cervical hardware failure. The interbody grafts were intact without signs of fracture or displacement. The pt was admitted to the intensive care unit where parenteral steroids were administered for 24 hours during monitored intubation. The pt was extubated on the second hospital day and discharged home on the fourth hospital day after swelling subsided.
Patient Sequence No: 1, Text Type: D, B5
[21829358]
(b)(4). Literature citation: perri, et al. Adverse swelling associated with the use of rh-bmp-2 in anterior cervical discectomy and fusion: a case study. The spine journal, 2007; 7: 235-239. Neither the device nor test results nor imaging films were returned to the manufacturer for eval. A review of the device history records is not possible without additional device info. Therefore, we are unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-01133 |
| MDR Report Key | 1831044 |
| Report Source | 03,05 |
| Date Received | 2010-09-07 |
| Date of Report | 2010-08-18 |
| Date of Event | 2006-04-05 |
| Date Mfgr Received | 2010-08-18 |
| Date Added to Maude | 2010-09-14 |
| 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 USA, INC. |
| Manufacturer Street | 4340 SWINNEA RD |
| Manufacturer City | MEMPHIS TN 38118 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38118 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT |
| Generic Name | INFUSE BONE GRAFT |
| Product Code | MPW |
| Date Received | 2010-09-07 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Manufacturer Address | 4340 SWINNEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-09-07 |