MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-24 for OPTIMESH 330-2705 manufactured by Spineology Inc..
[114932840]
Patient underwent an instrumented 3-level lumbar interbody fusion procedure at l2-3, l3-4 and l4-5. Patient awoke post-op with bilateral numbness in lower extremities. Immediate ct showed migration of graft/implant at l2-3 and l4-5, with allograft bone in central canal. It was noted that rod reduction caused straightening of the curved rods, indicating significant mechanical force had been applied. Patient was returned to the or for decompression of the central canal and removal of interbody implants at l2-3 and l4-5. Allograft bone was placed in the disc spaces at those levels and additional dorsal grafting was performed. Patient was discharged on pod #5 with residual numbness in both lower extremities and is receiving physical therapy. Numbness is reported to be improving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135156-2018-00006 |
| MDR Report Key | 7716285 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-24 |
| Date of Report | 2018-06-26 |
| Date of Event | 2018-06-26 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2015-03-01 |
| Date Added to Maude | 2018-07-24 |
| 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 | 6512568513 |
| 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 | 3 |
| Brand Name | OPTIMESH |
| Generic Name | GRAFT CONTAINMENT DEVICE |
| Product Code | EZX |
| Date Received | 2018-07-24 |
| Catalog Number | 330-2705 |
| Lot Number | S14252 |
| 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 | 1. Required No Informationntervention | 2018-07-24 |