MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-01 for INFUSE BONE GRAFT 7510400 manufactured by Medtronic Sofamor Danek, Inc..
[81487581]
Patient Sequence No: 1, Text Type: N, H10
[81487582]
The glass vial in the pack was found broken when opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6756511 |
| MDR Report Key | 6756511 |
| Date Received | 2017-08-01 |
| Date of Report | 2017-07-10 |
| Date of Event | 2017-06-28 |
| Report Date | 2017-07-10 |
| Date Reported to FDA | 2017-07-10 |
| Date Reported to Mfgr | 2017-07-10 |
| Date Added to Maude | 2017-08-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSE BONE GRAFT |
| Generic Name | FILLER, RECOMBINANT HUMAN BONE |
| Product Code | MPW |
| Date Received | 2017-08-01 |
| Catalog Number | 7510400 |
| Lot Number | M111613AAC |
| Device Expiration Date | 2018-11-30 |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK, INC. |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-01 |