MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-08 for OPTIMESH IMPLANT 330-2705 manufactured by Spineology, Inc..
[116775797]
Pt underwent minimally-invasive fusion of l2, l3 and l4. Bone graft (bg) was placed and post-op xrays reported showed bgs with good placement. In rr, pt c/o bilateral foot numbness and inability to dorsiflex or plantar flex feet. Ct showed bg material extruding from l4 and l2. The pt was returned to operating room and surgeon removed the bg bags from l4 and l2. Unable to get all of the bg material out.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5078972 |
| MDR Report Key | 7768715 |
| Date Received | 2018-08-08 |
| Date of Report | 2018-07-27 |
| Date of Event | 2018-06-25 |
| Date Added to Maude | 2018-08-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | 0 |
| Brand Name | OPTIMESH IMPLANT |
| Generic Name | MESH, SURGICAL, METAL |
| Product Code | EZX |
| Date Received | 2018-08-08 |
| Catalog Number | 330-2705 |
| Lot Number | S14252 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY, INC. |
| Manufacturer Address | 7800 3RD STREET NORTH STE 600 ST. PAUL MN 551285455 US 551285455 |
| Brand Name | OPTIMESH IMPLANT |
| Generic Name | MESH, SURGICAL, METAL |
| Product Code | EZX |
| Date Received | 2018-08-08 |
| Catalog Number | 330-2505 |
| Lot Number | S80143 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY, INC. |
| Manufacturer Address | 7800 3RD STREET NORTH STE 600 ST. PAUL MN 551285455 US 551285455 |
| Brand Name | OPTIMESH IMPLANT |
| Generic Name | MESH, SURGICAL, METAL |
| Product Code | EZX |
| Date Received | 2018-08-08 |
| Catalog Number | 530-6545 |
| Lot Number | S80551 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY, INC. |
| Manufacturer Address | 7800 3RD STREET NORTH STE 600 ST. PAUL MN 551285455 US 551285455 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-08 |