MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-04 for OPTIMESH 330-2205 manufactured by Spineology, Inc..
[140952046]
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Patient Sequence No: 1, Text Type: N, H10
[140952047]
During a lumbar interbody fusion procedure a ventral defect was identified in the annulus, which the surgeon suspected was caused during the discectomy. A mesh with bone graft was placed into the intervertebral disc space but a fluoroscopic image showed that the mesh was partially bulging ventrally through the annulus. The decision was made to remove the mesh but during this process the mesh was pushed anteriorly through the hole in the annulus and left there. The procedure was completed with a different implant without consequence and the patient awoke asymptomatic. At that point the decision was made to perform a revision surgery from an anterior approach to remove the mesh. The mesh was found intact and was fully removed. The revision surgery was completed without consequence and the patient remained asymptomatic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135156-2019-00002 |
| MDR Report Key | 8484225 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2018-02-01 |
| Date Added to Maude | 2019-04-04 |
| 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 | ANDREW ADAMS |
| Manufacturer Street | 7800 3RD 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 | 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 | MESH, GRAFT CONTAINMENT |
| Product Code | EZX |
| Date Received | 2019-04-04 |
| Catalog Number | 330-2205 |
| Lot Number | S80023 |
| 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 3RD STREET N. SUITE 600 SAINT PAUL MN 551285455 US 551285455 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-04 |