MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-12-30 for INFUSE BONE GRAFT 7510050 manufactured by Medtronic Sofamor Danek Usa, Inc.
[34684803]
(b)(6). (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.
Patient Sequence No: 1, Text Type: N, H10
[34684804]
It was reported that on an unknown date, post-op, patient had infection. The product came in contact with the patient. Therapy/procedure used by doctor: rhbmp-2/acs bone graft, site preservation, single tooth cases patient info: middle aged (50-60), nothing unusual implant site: #8 (signifies tooth number) kind of infection patient had: unknown; debrided each site; used "abx" on patient.
Patient Sequence No: 1, Text Type: D, B5
[35049700]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2015-03617 |
| MDR Report Key | 5335321 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-12-30 |
| Date of Report | 2015-12-03 |
| Date Mfgr Received | 2015-12-03 |
| Device Manufacturer Date | 2015-09-02 |
| Date Added to Maude | 2015-12-30 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | GREG ANGLIN |
| 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 | 2015-12-30 |
| Model Number | NA |
| Catalog Number | 7510050 |
| Lot Number | ML80484AAE |
| Device Expiration Date | 2016-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-12-30 |