MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-03 for OPTIMESH 330-2005 manufactured by Spineology Inc..
[69050214]
On (b)(6) 2017, the patient underwent a posterior lumbar spinal fusion with placement of a 1500e optimesh implant. Approximately 4 weeks following the surgical procedure, the patient experienced back pain and a fever. On (b)(6) 2017, the patient was returned to the operating room for posterior lumbar exploratory surgery at which time the physician identified an infection localized to the intervertebral disc space. The optimesh devices was removed and cultures were taken. A new interbody fusion device was not placed. Microbiological results of the culture identified an anerobic infection consistent with anaerobes commonly found in mucosal membranes. At an unspecified time following the re-operation procedure, the patient was again returned to the operating room for anterior lumbar placement of another manufacturer's interbody fusion device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135156-2017-00003 |
| MDR Report Key | 6377254 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-03 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-02-17 |
| Device Manufacturer Date | 2015-10-15 |
| Date Added to Maude | 2017-03-03 |
| 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 | 3 |
| Brand Name | OPTIMESH |
| Generic Name | SURGICAL MESH |
| Product Code | EZX |
| Date Received | 2017-03-03 |
| Catalog Number | 330-2005 |
| Lot Number | S14273 |
| 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 | 2017-03-03 |