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

Device Problem Unintended Movement (3026)

Patient Problems Pain (1994); Impaired Healing (2378); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

Patient height reported as 69 inches 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 study patient id (b)(6) was implanted with unknown anterior cervical discectomy fusion (acdf) device at levels c5-6 on (b)(6) 2003.No complications were reported intra-operatively.Patient was discharged on (b)(6) 2003.Post-operative non-union reported, unknown number of implants were explanted (b)(6) 2004 and patient underwent c5-c6 posterior instrumental fusion where patient was instrumented with additional unknown hardware (unknown quantity).The study was completed on (b)(6) 2010.Adverse event reported: date reported: 03august2005; event (b)(6) 2004: persistent neck and shoulder pain with numbness.Course of action: c5-6 instrumented fusion (b)(6) 2004.C5-6 pseudoarthrosis.Loose screws, c5-6 posterior instrumented fusion on (b)(6) 2004.Implants explanted.Patient hospitalized (b)(6) 2004-(b)(6) 2004.Date reported: 26february2007; event (b)(6) 2004: wound infection.Patient prescribed keflex 500mg.Date reported 21january2006; event (b)(6) 2005: myofascial neck pain with some upper extremity numbness.Patient continuing to see pain management physician for consideration of neurontin.Date reported: 16november2009; event (b)(6) 2009 (anticipated): pain and numbness down arms (ulnar distribution); x-ray revealed mild degenerative changes at adjacent segment, possible adjacent segment stenosis.No surgical course of action taken.This report is for adverse event: date reported: 03august2005; event (b)(6) 2004: persistent neck and shoulder pain with numbness.Course of action: c5-6 instrumented fusion (b)(6) 2004.It was noted in association with this event there were loose screws and a non-union.This report is for an unknown acdf device.This is report 1 of 1 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: 5288789
• MDR Text Key: 33260188
• Report Number: 2520274-2015-17794
• 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: 12/21/2004

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2004
• 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: 91