MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-22 for OSTEOSURGE 300 SSU-16-07241 manufactured by Seaspine Orthopedics Corporation.
[60684948]
Patient Sequence No: 1, Text Type: N, H10
[60684949]
Patient was implanted with bone putty that the vendor provided. The operating room staff, nor the vendor follow the tissue policies / protocols. There is no storage or temperature documentation related to the implanted bone putty. The patient medical record does not indicate that the bone putty was "tissue".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6121626 |
| MDR Report Key | 6121626 |
| Date Received | 2016-11-22 |
| Date of Report | 2016-10-07 |
| Date of Event | 2016-09-29 |
| Report Date | 2016-10-07 |
| Date Reported to FDA | 2016-10-07 |
| Date Reported to Mfgr | 2016-10-07 |
| Date Added to Maude | 2016-11-22 |
| 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 | OSTEOSURGE 300 |
| Generic Name | FILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) |
| Product Code | MBP |
| Date Received | 2016-11-22 |
| Model Number | SSU-16-07241 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEASPINE ORTHOPEDICS CORPORATION |
| Manufacturer Address | 5770 ARMADA DR. CARLSBAD CA 92008 US 92008 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-22 |