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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES USA; INTERVERTEBAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

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SYNTHES USA; INTERVERTEBAL FUSION DEVICE WITH BONE GRAFT, LUMBAR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Hernia (2240)
Event Type  Injury  
Event Description
This report is being filed after the subsequent review of the following journal article: galan, t.V., et al (2012).Case report: incisional hernia as a complication of extreme lateral interbody fusion.The spine journal, 12, p.E1-e6.This was retrospective review of a case report in which the purpose was to report the rare complication of an incisional hernia after minimal access lateral transpsoas approach for lumbar interbody fusion.The case report involved one (b)(6) female with a history of low back and left lower extremity pain.Imaging studies results: grade i spondylolisthesis of l4 on l5 with resultant ventral and foraminal stenosis.She tried and failed non-operative treatment including epidural injections and pain medications.Patient had a lateral and posterior spinal fusion via lateral access approach interbody fusion at l4-5 with oracle, with l4-5 posterior spinal fusion with constellation instrumentation via percutaneous mis technique.Four weeks after surgery, patient had tender prominence over lateral surgical incision on flank and later diagnosed with a hernia (based on ct scan).She had laparoscopic repair and was able to resume normal activities.This report is 1 of 2 for (b)(4).This report is for an unknown oracle.
 
Manufacturer Narrative
Galan, t.V., et al (2012).Case report: incisional hernia as a complication of extreme lateral interbody fusion.The spine journal, 12, p.E1-e6.This report is for unknown oracle/unknown quantity/unknown lot.(b)(6).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Type of Device
INTERVERTEBAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
Manufacturer (Section D)
SYNTHES USA
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
linda plews
1302 wrights lane east
west chester, PA 19380
6107195000
MDR Report Key4274853
MDR Text Key5295968
Report Number2520274-2014-14944
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeSZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 10/31/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/24/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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