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 |