MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-28 for OPTIMESH 330-2705 manufactured by Spineology Inc..
[125448878]
Patient Sequence No: 1, Text Type: N, H10
[125448879]
Patient awoke with new leg pain following lumbar fusion surgery. A follow-up ct identified bone graft in the central canal at l3-l4. A second surgery was performed two days later. A laminectomy was performed at l2-l3 and bone graft was removed from the canal at l2-l3 and at l3-l4, and intraoperative neuromonitoring showed immediate improvement. The implant and a large piece of disc material were both removed from the l3-l4 disc space and replaced with an expandable fusion cage and allograft. The symptoms are reported to be resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135156-2018-00009 |
| MDR Report Key | 8012455 |
| Date Received | 2018-10-28 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-10-09 |
| Date Added to Maude | 2018-10-28 |
| 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 | MS KAREN ROCHE |
| Manufacturer Street | 7800 THIRD STREET N. SUITE 600 |
| Manufacturer City | SAINT PAUL MN 551285455 |
| Manufacturer Country | US |
| Manufacturer Postal | 551285455 |
| Manufacturer Phone | 6512568500 |
| Manufacturer G1 | SPINEOLOGY INC |
| Manufacturer Street | 7800 THIRD STREET N SUITE 600 |
| Manufacturer City | SAINT PAUL MN 551285455 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551285455 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTIMESH |
| Generic Name | SURGICAL MESH |
| Product Code | EZX |
| Date Received | 2018-10-28 |
| Catalog Number | 330-2705 |
| Lot Number | S17779 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY INC. |
| Manufacturer Address | 7800 THIRD STREET N. SUITE 600 SAINT PAUL MN 551285455 US 551285455 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-28 |