MAUDE Adverse Event Report: SYNTHES USA; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problems Unspecified Infection (1930); Pain (1994); Impaired Healing (2378); No Code Available (3191)

Event Date 08/03/2006

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for unknown ventrofix ®/unknown quantity/unknown lot.(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.

Event Description

This report is being filed after the subsequent review of the following literature article: frangen, t., kČike, t., gottwald, m., andereya, s., andress, h., russe, o.,.Schinkel, c.(2006, august 3).Surgical therapy for spondylodiscitis an analysis of 78 patients.The trauma surgeon 9, 743-753.Germany in the period from july 1992 to september 2001, a total of 78 patients underwent an operation at the surgical hospital of the bergmannsheil employer's liability insurance association hospitals in bochum or on the trauma surgery ward at the surgical hospital of ludwig maximilian university in munich, grosshadern clinical center, due to a specific (4 patients) or non-specific (74 patients) form of spondylodiscitis.At the time of the operation, the average age was 64 years (+/-6 years, ranging from 21-80 years).The joint patient populations consisted of 53 men (68%) and 25 women (32%).Besides customary laboratory testing, conventional x-ray imaging at 2 levels and computer tomography with ct-controlled puncture was performed on all of the patients as standard diagnostics.In order to assess the surrounding soft tissue and determine any spinal cord involvement, these diagnostics were supplemented by an mri.We carried out scintigraphy if there were multiple foci or if performing an mri was impossible.The operation was carried out either from the dorsal or the ventral side (one or two-stage approach), depending on the location and spread of the infection focus.For ventral implants, we used the synex system and the ventrofix and we used the uss or dorsal stabilization (all of them from synthes).The 10 cages that we used were all harms titanium cages.Patients required a revision intervention due to the formation of a new abscess (n = 4).In these cases, an abscess was cleared out (n = 4).Four wound infections were reported.Before the operation, all of the patients suffered from pain symptoms of greater or lesser severity, with all of the patients indicating that their need for analgesics was very high.At the time of the follow-up examination, 33 patients (48%) indicated that they were still suffering from pain; of these, 18 had experienced partial relief from the pain symptoms, with no improvement for 15.Nine patients (13%) reported slight impairment, whereby they were only incapable of performing activities like lifting heavy objects.12 patients (17%) indicated moderate impairment.Another 17 patients (25%) complained of severe impairment, while 11 patients were confined to a wheelchair with irreversible paraplegia, and 4 patients were only able to be mobilized with the aid of a walking frame and/or help from nursing staff.This is report 3 of 6 for (b)(4).This report is for an unknown ventrofix.

Manufacturer Narrative

Device was not used for treatment, nor diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Four patients who had hemorrhaging.

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 5180122
• MDR Text Key: 29331099
• Report Number: 2520274-2015-16596
• 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,Followup
• Report Date: 10/06/2015

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: 10/06/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/06/2015
• 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