MAUDE Adverse Event Report: SPINEOLOGY INC. OPTIMESH DEPOLYABLE GRAFT CONTAINMENT DEVICE; SURGICAL MESH

Catalog Number	330-2505
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
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.

• Brand Name: OPTIMESH DEPOLYABLE GRAFT CONTAINMENT DEVICE
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 third street north; suite 600; saint paul MN 55128 5455
• MDR Report Key: 8011741
• Report Number: 2135156-2018-00007
• Device Sequence Number: 19187770
• Product Code: EZX
• UDI-Device Identifier: M7403302505
• UDI-Public: M7403302505
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K014200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/15/2021
• Device Catalogue Number: 330-2505
• Device Lot Number: S15629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR