MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for INFUSE BONE GRAFT 7510100 manufactured by Medtronic Sofamor Danek Usa, Inc..
[135522998]
A medtronic bone graft package was opened for use in the operating room. Upon inspection of the sealed package, a small lizard-type creature was identified possibly of the gecko species.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8319918 |
| MDR Report Key | 8319918 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-02-07 |
| Report Date | 2019-02-07 |
| Date Reported to FDA | 2019-02-07 |
| Date Reported to Mfgr | 2019-02-08 |
| Date Added to Maude | 2019-02-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH |
| Product Code | NEK |
| Date Received | 2019-02-08 |
| Model Number | 7510100 |
| Lot Number | M111806AAE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC SOFAMOR DANEK USA, INC. |
| Manufacturer Address | 1800 PYRAMID PLACE MEMPHIS TN 38132 US 38132 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |