MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-03 for OPTIMESH 330-2005 manufactured by Spineology Inc..
[39979141]
The optimesh device was not returned to spineology following its removal and is not expected to be returned at a later date.
Patient Sequence No: 1, Text Type: N, H10
[39979142]
An optimesh device was implanted in the l5-s1 intervertebral disc space on an unknown date. Approximately 4 weeks following the implant procedure, the patient presented with discitis symptoms and lower back pain that increased with sitting or standing. The patient reported that while bending over they felt something pop in their lower back and experienced left lower extremity pain. The physician ordered an mri which revealed reaction around the optimesh device and the appearance of bone in the neural foramen. A fine needle aspirate of the l5-s1 disc space was performed and results were negative for infectious material. A second surgical procedure was performed at which time the physician noted that the optimesh had torn and bone had entered into the left neural foramen. No evidence of infection was identified. The physician removed the optimesh device and replaced it with iliac crest autograft. The patient's left lower extremity pain resolved following the second surgical procedure. It was further reported that during the initial surgical procedure that the physician recalls hitting the optimesh bone fill push rod "pretty hard" in an attempt to get distraction of a "very tight disc space". It is not know whether this action caused or contributed to the torn optimesh device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135156-2016-00001 |
| MDR Report Key | 5476359 |
| Date Received | 2016-03-03 |
| Date of Report | 2016-03-01 |
| Date of Event | 2016-01-15 |
| Date Mfgr Received | 2016-02-25 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2016-03-03 |
| 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 | JACQUELINE HAUGE |
| Manufacturer Street | 7800 3RD STREET N SUITE 600 |
| Manufacturer City | ST. 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 | 0 |
| Brand Name | OPTIMESH |
| Generic Name | SURGICAL MESH |
| Product Code | EZX |
| Date Received | 2016-03-03 |
| Catalog Number | 330-2005 |
| Lot Number | S14025 |
| Device Expiration Date | 2019-03-01 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SPINEOLOGY INC. |
| Manufacturer Address | 7800 3RD STREET N SUITE 600 ST PAUL MN 551285455 US 551285455 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-03 |