MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03,05 report with the FDA on 2014-12-19 for INFUSE BONE GRAFT 7510200 manufactured by Medtronic Sofamor Danek Usa, Inc.
[18289983]
It was reported in a publication that a study was conducted on 150 individuals submitted to alveolar graft (ag) surgery at the hospital for rehabilitation of craniofacial anomalies at university of sao paulo (hrac-usp) between april and october 2012. In all surgeries, the cleft area was filled using rhbmp-2. A small kit (two membranes) was used for each cleft. Each membrane was soaked with 1. 4 ml of rhbmp-2 solution at a concentration of 1. 5 mg/ml, adding up to 4. 2 mg of rhbmp-2 for each cleft the form for data collection was filled preoperatively at the maxillofacial surgery sector of hrac-usp, and the complementary data were collected on the 4 days after ag surgery by a single examiner. Maximum facial edema occurred in 72 individuals on day 4, in 62 individuals on day 3, and in 13 individuals on day 2. No individual presented maximum edema on day 1, and one individual did not present facial edema throughout the evaluation period. Female patients presented greater percentage of increase in the basal facial measurement compared to the male patients.
Patient Sequence No: 1, Text Type: D, B5
[18643434]
Article citation: leal et al. Evolution of postoperative edema in alveolar graft performed with bone morphogenetic protein (rhbmp-2). Cleft palate craniofac j. 2014 dec 1. April - october 2012. University of sao paulo medical school, sao paulo, br 04140. (b)(4). Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2014-04797 |
| MDR Report Key | 4346562 |
| Report Source | 03,05 |
| Date Received | 2014-12-19 |
| Date of Report | 2014-12-06 |
| Date of Event | 2014-12-01 |
| Date Mfgr Received | 2014-12-06 |
| Date Added to Maude | 2014-12-19 |
| 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 | HUZEFA MAMOOLA |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | MEDTRONIC SOFAMOR DANEK |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT |
| Generic Name | BONE GRAFTING MATERIAL, DENTAL, WITH BIOLOGIC COMPONENT |
| Product Code | NPZ |
| Date Received | 2014-12-19 |
| Model Number | NA |
| Catalog Number | 7510200 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC |
| Manufacturer Address | 4340 SWINEA RD MEMPHIS TN 38118 US 38118 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-19 |