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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SPINEOLOGY INC. OPTIMESH; SURGICAL MESH
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SPINEOLOGY INC. OPTIMESH; SURGICAL MESH Back to Search Results
Catalog Number 330-2705
Health Effect - Clinical Code Pain (1994)
Date of Event 10/03/2018
Type of Reportable Event Malfunction
Event or Problem Description
Patient awoke with new leg pain following lumbar fusion surgery.A follow-up ct identified bone graft in the central canal at l3-l4.A second surgery was performed two days later.A laminectomy was performed at l2-l3 and bone graft was removed from the canal at l2-l3 and at l3-l4, and intraoperative neuromonitoring showed immediate improvement.The implant and a large piece of disc material were both removed from the l3-l4 disc space and replaced with an expandable fusion cage and allograft.The symptoms are reported to be resolved.
 
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Brand Name
OPTIMESH
Common Device Name
SURGICAL MESH
Manufacturer (Section D)
SPINEOLOGY INC.
7800 third street n.
suite 600
saint paul MN 55128 5455
MDR Report Key8012455
Report Number2135156-2018-00009
Device Sequence Number13795308
Product Code EZX
UDI-Device IdentifierM7403302705
UDI-PublicM7403302705
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K014200
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
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? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date11/01/2022
Device Catalogue Number330-2705
Device Lot NumberS17779
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/09/2018
Initial Report FDA Received Date10/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age67 YR
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