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

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(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

It was reported clinical prodisc-c study patient id 03-037 had a hematoma removed on an unknown date in (b)(6) 2010.The patient underwent an anterior cervical decompression fusion (acdf) at c5-c6 levels on (b)(6) 2004.The patient was discharged home on (b)(6) 2004.Discharge medications were valium 5mg every 4-6 hours and vicodin 5/325mg every 4-6 hours.The study was completed (b)(6) 2012.The following adverse events were reported postoperatively: (b)(6) 2010: the patient experienced neck and upper extremity pain and underwent a removal surgery of an unknown plate at c5-6 and was revised to an anterior cervical fusion (acf) at c4-c5 on (b)(6) 2010.Issue resolved.(b)(6) 2010: patient complained of pain at incision site and flu like symptoms.Incision and drain was done to clean out infection and remove fluid collection.Patient tolerated surgery well and wound was fully healed.Likelihood-unanticipated, severity: severe, implant involvement: none, related to implant: definitely not, related to surgery: definitely.(b)(6) 2008: patient experienced neck pain.Pain has been resolved.Likelihood: unanticipated, severity: mild, implant involvement: none, impairments: none, related to implant or surgery: possibly.(b)(6) 2008: numbness and tingling bilaterally in hands and feet.Patient will follow-up with physician if pain gets worse.Likelihood: unanticipated, severity: moderate, impairments: one, related to implant or surgery: definitely not.This report is for adverse event: patient complained of pain at incision site and flu like symptoms.Incision and drain was done to clean out infection and remove fluid collection.Patient tolerated surgery well and wound was fully healed.Likelihood-unanticipated, severity-severe, implant involvement-none, related to implant-definitely not, related to surgery-definitely.This report is for an unknown acdf device.This is report 2 of 2 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: 5289749
• MDR Text Key: 33303580
• Report Number: 2520274-2015-17815
• 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: 03/30/2010

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2010
• Initial Date FDA Received: 12/11/2015
• 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: 86