MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problem Insufficient Information (3190)

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Myalgia (2238); Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as (b)(6).This report is for an unknown acdf device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.

Event Description

(b)(4) study patient (b)(6) was implanted with an anterior cervical discectomy and fusion (acdf) implant at c5-c6 on (b)(6) 2004.No complications were noted during surgery.Patient was discharged on (b)(6) 2004.Study was completed on (b)(6) 2013.The following complications were noted (date reported, event, intervention, status): (b)(6) 2007: unanticipated severe neck and upper extremity pain intervention: surgery to be scheduled on (b)(6) 2007 status: ongoing.(b)(6) 2007: unanticipated severe surgery at c6-7.Plate was removed.Intervention: removed implant acf and removed of plate status: resolved.(b)(6) 2008: unanticipated moderate increased neck pain intervention: patient to get computed tomography status: ongoing.(b)(6) 2009: unanticipated severe revision c6-c7 anterior cervical discectomy c4-c5 intervention: revision surgery status: ongoing.(b)(6) 2010: anticipated moderate dysphagia intervention: patient to make appointment with ears, nose, throat for examination status: ongoing.(b)(6) 2010: unanticipated moderate right shoulder and trapezius muscle pain, numbness bilateral upper extremity (bue) right greater than left intervention: patient to get electromyography status: ongoing.(b)(6) 2010: anticipated severe neck pain with evidence of pseudoarthrosis at c6-c7 (index level is c5-c6) intervention: patient underwent posterior cervical fusion c5-c7 status: resolved.(b)(6) 2011: anticipated moderate neck spasms secondary to posterior cervical fusion intervention: patient has increasing neck spasms secondary to posterior cervical fusion status: ongoing.This report is for adverse event: 1.(b)(6) 2007: unanticipated severe neck and upper extremity pain.Action required: plan for surgery on (b)(6) 2007.Course of action: surgery to be scheduled on (b)(6) 2007.Implant involvement: none.Related to surgery: possibly.Related to implant: possibly.Current state of event: ongoing.Patient awaiting surgery.2.(b)(6) 2007 unanticipated severe surgery at c6-7.Plate was removed.Intervention: removed implant acf and removed of plate status: resolved.This report is for an unknown acdf device.This is report 1 of 4 for (b)(4).

• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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 Key: 5292883
• MDR Text Key: 33398809
• Report Number: 2520274-2015-17848
• Device Sequence Number: 1
• Product Code: KWQ
• 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,study
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2007

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• 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: 10/01/2007
• 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
• Patient Weight: 69