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U.S. Department of Health and Human Services

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

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SPINEOLOGY INC. OPTIMESH; INTERVERTEBRAL BODY GRAFT CONTAINMENT Back to Search Results
Catalog Number 300-3440
Device Problem Insufficient Information (3190)
Patient Problem Pain (1994)
Event Date 01/25/2023
Event Type  Injury  
Manufacturer Narrative
The information contained in this report is being provided to fda to comply with medical device reporting regulations and is based on information submitted by others that may not be factually correct.This submission does not constitute a determination of admission that a device has malfunctioned or that a device is related to an injury or death.Pursuant to manufacturer policy, events resulting in a revision surgery are deemed a serious injury as defined in 21 cfr 803.3 and are determined to be mdr reportable events.
 
Event Description
The patient underwent an interbody fusion procedure with placement of an optimesh device without incident.Approximately one (1) month later, the patient experienced recurring back pain, prompting medical attention.Imaging showed presence of bone graft in the foraminal space per surgeon interpretation.A revision surgery was conducted on (b)(6) 2023 to remove and replace the implant.
 
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Brand Name
OPTIMESH
Type of Device
INTERVERTEBRAL BODY GRAFT CONTAINMENT
Manufacturer (Section D)
SPINEOLOGY INC.
7800 3rd street n.
suite 600
saint paul MN 55128 5455
Manufacturer (Section G)
SPINEOLOGY INC.
7800 3rd street n.
suite 600
saint paul MN 55128 5455
Manufacturer Contact
megan polos
7800 3rd street n.
suite 600
saint paul, MN 55128-5455
MDR Report Key16418765
MDR Text Key309986952
Report Number2135156-2023-00001
Device Sequence Number1
Product Code OQB
UDI-Device IdentifierM74030034400
UDI-Public+M74030034400/$$3270801S24136D
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DEN200010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/22/2023
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
Device Operator Health Professional
Device Catalogue Number300-3440
Device Lot NumberS24136
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/26/2023
Initial Date FDA Received02/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/13/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age64 YR
Patient SexMale
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