MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2010-05-28 for INFUSE BONE GRAFT UNK manufactured by Medtronic Sofamor Danek Usa, Inc..
[1510053]
It was reported that a pt underwent a procedure to close an alveolar defect using infuse. It was reported post-op that the pt experienced prolonged wound healing and granulation tissue growth. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[8554215]
(b) (4). Granulation tissue formation. Literature article citation: dickinson et al. Reduced morbidity and improved healing with bone morphogenic protein-2 in older pts with alveolar cleft defects. Plastic and reconstructive surgery journal 2008; 209-217. A review of the certificates of analysis and packing list for the infuse bone graft was not possible without additional device info. Neither the device nor films of applicable imaging studies were returned to the manufacturer for eval. Therefore we are unable to determine the definitive cause of the reported event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2010-00754 |
| MDR Report Key | 1705942 |
| Report Source | 03,05 |
| Date Received | 2010-05-28 |
| Date of Report | 2010-04-28 |
| Date of Event | 2006-07-18 |
| Date Facility Aware | 2006-07-15 |
| Report Date | 2010-04-28 |
| Date Mfgr Received | 2010-04-28 |
| Date Added to Maude | 2010-06-04 |
| 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 | NPZ |
| Date Received | 2010-05-28 |
| 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 | 2010-05-28 |