MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-06 for OPTIMESH 330-2505 manufactured by Spineology Inc..
[126297226]
Patient Sequence No: 1, Text Type: N, H10
[126297227]
During placement of the implant and graft for a lumbar interbody fusion procedure, a portion of the device was filled into the spinal canal, resulting in cauda equina syndrome. Patient was returned to surgery due to postoperative symptoms. The surgeon reported that the device was found intact but protruding in the canal. It was removed and replaced with an interbody spacer. Patient is reported to have impaired bladder control, limited plantar flexion and dorsiflexion, and lower extremity numbness which is gradually improving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135156-2018-00011 |
| MDR Report Key | 8043440 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-06 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-10-22 |
| Device Manufacturer Date | 2018-05-01 |
| Date Added to Maude | 2018-11-06 |
| 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 3RD STREET N. SUITE 600 |
| Manufacturer City | ST. PAUL MN 551285455 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 551285455 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIMESH |
| Generic Name | MESH, GRAFT CONTAINMENT |
| Product Code | EZX |
| Date Received | 2018-11-06 |
| Catalog Number | 330-2505 |
| Lot Number | S80298 |
| 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, |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2018-11-06 |