MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2010-08-13 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[1358954]
It was reported that the pt had less than 4mm of residual crestal bone requiring bilateral sinus augmentation. The lateral sinus wall was exposed, a complete osteotomy was made and the lateral window bone was discarded. Initial sinus membrane release was accomplished and extended up the medial wall of the sinus - no perforations were observed. Preparation of rhbmp-2/acs was done per mfr's instructions. The sinuses were grafted with infuse graft at a concentration of 1. 5 mg/ml/acs combined a mineralized allograft. The collagen sponges were compressed after a 15-minute binding period to remove any excess water. Half of the particles were 0. 5 to 1 mm and half were 1 to 2 mm. On the left side, two sponges were cut into strips and mixed with the allograft as a composite graft, while four spongs were used on the right. The total volume of rhbmp-2 on the right was twice that used on the left. Barrier membranes were not used over the lateral window. Extensive postoperative inflammatory response was observed, which had resolved by the 6-month evaluation.
Patient Sequence No: 1, Text Type: D, B5
[8776535]
(b)(4). Literature citation: tamrow, et al. Maxillary sinus augmentation using recombinant bone morphogenetic protein-2/acellular collagen sponge in combination with a mineralized bone replacement graft: a report of three cases. Int j periodontics restorative dent 2010;30:139-149. A review of the device history records is not possible without additional device info. Neither the device nor (test results or imaging films) were returned to the mfr for evaluation. Therefore, we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-01050 |
| MDR Report Key | 1805098 |
| Report Source | 03,05 |
| Date Received | 2010-08-13 |
| Date of Report | 2010-07-18 |
| Date of Event | 2010-01-01 |
| Date Mfgr Received | 2010-07-18 |
| Date Added to Maude | 2010-08-20 |
| 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 | 0 |
| 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 | NPZ |
| Date Received | 2010-08-13 |
| 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 | 2010-08-13 |