MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-10-28 for OPTIMESH DEPOLYABLE GRAFT CONTAINMENT DEVICE 330-2505 manufactured by Spineology Inc..
[125275050]
Patient Sequence No: 1, Text Type: N, H10
[125275051]
A single-level lumbar interbody fusion procedure at l4-l5 was performed on (b)(6) 2018. Intraoperatively, a ventral defect was identified in the annulus, which the surgeon suspected was caused by a pituitary rongeur during the discectomy procedure. A bmp sponge and an implant with bone graft were placed into the intervertebral disc space, with no intraoperative indications of any problem. Per this surgeon's standard procedure, a postoperative ct was taken, which indicated bone in front of the spine against the iliac vein. A venogram confirmed compression on the vein. Due to a history of dvt in this patient, a decision was made to remove the graft from the retroperitoneal space. A revision surgery was performed on (b)(6) 2018. The surgeon found that the implant had migrated through the defect created in the ventral annulus. No loose bone graft was observed. The surgeon cut the protruding portion and left the remainder of implant and graft in the disc space. The patient is reported to be doing well, with good relief of pre-operative low back symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135156-2018-00007 |
| MDR Report Key | 8011741 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-10-28 |
| Date of Report | 2018-10-26 |
| Date of Event | 2018-10-03 |
| Date Mfgr Received | 2018-10-03 |
| Device Manufacturer Date | 2016-04-15 |
| Date Added to Maude | 2018-10-28 |
| 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 | SPINEOLOGY INC. 7800 THIRD STREET N. |
| Manufacturer City | SUITE 600 MN 551285455 |
| Manufacturer Country | US |
| Manufacturer Postal | 551285455 |
| Manufacturer Phone | 6512568500 |
| 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 DEPOLYABLE GRAFT CONTAINMENT DEVICE |
| Generic Name | SURGICAL MESH |
| Product Code | EZX |
| Date Received | 2018-10-28 |
| Catalog Number | 330-2505 |
| Lot Number | S15629 |
| 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 NORTH SUITE 600 SAINT PAUL MN 551285455 US 551285455 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-28 |