MAUDE Adverse Event Report: SYNTHES USA; SYNFRAME STANDARD ACCESS SYSTEM, EVAL, SALES SAMPLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paresis (1998); Impaired Healing (2378); No Code Available (3191)

Event Date 10/21/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown syncage, unknown quantity, unknown lot.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.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Literature article received.This report is being filed after the subsequent review of the following literature article: lechner, r., et al.(2016) fusion rate and clinical outcome in anterior lumbar interbody fusion with beta-tricalcium phosphate and bone marrow aspirate as a bone graft substitute.A prospective clinical study in fifty patients.International orthopaedics (sicot) 41:333-339.Patients with lower-back pain and degenerative disc disease (ddd) or degenerative spondylolisthesis between l3 and s1 were included in this study.The syncage (synthes, (b)(4)) is a peek (polyether ether ketone) cage prefilled with chronos.All alif procedures were performed by the same surgeon.In all patients the syncage was implanted as alif cage.Additional posterior fixation with pedicle screws (clickx; synthes, (b)(4)) was performed in all patients.Fifty patients were enrolled in the study; 19 female and 31 male; 23 smokers; 27 non-smokers; patient age between 18 and 80 years.Complications included the following: 1 patient experienced paresis l5, 1 patient experienced haematoma, 1 patient experienced vessel lesion (superficial epigastric artery), 9 nonunion, 5 pseudoarthroses, inadequate fusion.This is report 1 of 2 for (b)(4).This report is for an unknown syncage.

• Type of Device: SYNFRAME STANDARD ACCESS SYSTEM, EVAL, SALES SAMPLE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6506491
• MDR Text Key: 73222902
• Report Number: 2520274-2017-11398
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• 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?: No
• Date Manufacturer Received: 03/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention