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..
[1705643]
It was reported that complications were observed in pts who had undergone anterior cervical discectomy and fusion (acdf) augmented with high-dose rhbmp-2. The surgical procedure was performed using a modified surgical technique. Decompression and decortication were carried out and the cage was filled with rhbmp-2. Add'l rhbmp-2 was also placed lateral and anterior to the graft within the disc space - up to 2. 1 mg/level was used. An anterior cervical plate was then placed. Intraoperative radiograph confirmed proper alignment and fixation of the bone graft and plate. It was reported that between four and five days postoperatively four pts who had undergone a single-level acdf developed a hematoma. A drain was placed - surgical evacuation was not required. Not details or outcomes were mentioned.
Patient Sequence No: 1, Text Type: D, B5
[8704161]
(b)(4). Literature citation: shields et al. Adverse effects associated with high-dose recombinant human bone morphogenetic protein-2 used in anterior cervical spine fusion. Spine. 2006; 31: number 5, pp 542-547. Device was not returned to the mfr for eval. Without add'l device info, a review of the device history records is not possible. We are, therefore, unable to determine the cause of the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-01144 |
| MDR Report Key | 1831031 |
| Report Source | 03,05 |
| Date Received | 2010-09-07 |
| Date of Report | 2010-08-16 |
| Date of Event | 2005-03-14 |
| Date Mfgr Received | 2010-08-16 |
| 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. Required No Informationntervention | 2010-09-07 |