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); Inflammation (1932); Nerve Damage (1979); No Code Available (3191)

Event Date 05/17/2006

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown (ventrofix hardware /unknown quantity/unknown lot.(other number) udi: unknown part number, udi is unavailable.(b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following literature linhardt, o; matussek, j; refior, h and krodel, a.(2007).Long-term results of ventro-dorsal versus ventral instrumentation fusion in the treatment of spondylitis.International orthopaedics, 31,113-119.This study examines prospectively the randomised, long-term, clinical and radiological results of the treatment of spondylitis patients by ventro-dorsal or ventral spine fusion.Group 1 consisted of 12 patients who (after ventral removal of the focus of infection and autologous bone grafting) were treated by dorsal instrumentation.Group 2 consisted of ten patients who, after similar ventral removal and bone interposition, were stabilised by ventral instrumentation.From (b)(6) 1997 to (b)(6) 1998, of the randomly assigned patients with spondylitis 12 underwent ventrodorsal instrumentation fusion and ten underwent ventral instrumentation fusion.The group that was treated by ventro-dorsal spondylodesis (group 1) consisted of eight male and four female patients.At the time of the operation the age of the patients ranged from 20 years to 75 years, the average age being 57.2 years.Patients from group 2 were treated by ventral spondylodesis.There were eight male and two female patients, having an average age at the time of the operation of 59.5 years (range 25-70 years).The postoperative follow-ups were at 6 months, 2 years and 5.4 years.This is report 2 of 4 for (b)(4).This report is for ventrofix hardware and refers to ventrofix system and refers to following adverse events: eight patients had one vertebral segment was affected, and in two patients two segments were affected by the inflammatory process, yielding an average of 1.2 segments.The removal of the ventral focus of infection was reported on average, 2.1 segments.Three patients had post-operative, transitory lesion of the peroneal nerve (fibula graft).One patient had immediate post-operative urinary tract infection, adynamic ileus and postoperative psychosis.One patient had 4 months post-operatively, spondylitis in another spine segment.

• 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: 5636737
• MDR Text Key: 44582376
• Report Number: 2520274-2016-12510
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2016

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
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/06/2016
• 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