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

Catalog Number	330-2505
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	06/26/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent an instrumented 3-level lumbar interbody fusion procedure at l2-3, l3-4 and l4-5.Patient awoke post-op with bilateral numbness in lower extremities.Immediate ct showed migration of graft/implant at l2-3 and l4-5, with allograft bone in central canal.It was noted that rod reduction caused straightening of the curved rods, indicating significant mechanical force had been applied.Patient was returned to the or for decompression of the central canal and removal of interbody implants at l2-3 and l4-5.Allograft bone was placed in the disc spaces at those levels and additional dorsal grafting was performed.Patient was discharged on pod #5 with residual numbness in both lower extremities and is receiving physical therapy.Numbness is reported to be improving.

• Brand Name: OPTIMESH
• Common Device Name: GRAFT CONTAINMENT DEVICE
• Manufacturer (Section D): SPINEOLOGY INC.; 7800 third street n.; suite 600; saint paul MN 55128 5455
• MDR Report Key: 7716484
• Report Number: 2135156-2018-00005
• Device Sequence Number: 13891695
• Product Code: EZX
• UDI-Device Identifier: M7403302505
• UDI-Public: M7403302505
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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: 03/01/2023
• Device Catalogue Number: 330-2505
• Device Lot Number: S80143
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 07/24/2018
• 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