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

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis beisse, r., potulski, m., berger, j., bühren, v., (2002) development and clinical application of a thoracoscopically implantable frame plate for treatment of thoracolumbar fractures and instability.Orthopäde, volume 31, pages 413-422.This report is for an unknown nut/unknown quantity/unknown lot.(b)(4) destruction of titanium threading of screw.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 article: beisse, r., potulski, m., berger, j., b܈ren, v., (2002) development and clinical application of a thoracoscopically implantable frame plate for treatment of thoracolumbar fractures and instability.OrthopĄe, volume 31, pages 413-422.Germany article.This is a report of the modular anterior construct system (macs-tl system) used for stabilizing the ventral section of the truncal spine that was the first implant specifically designed to meet requirements of endoscopic and minimally invasive surgical procedures.The results of the first 100 implantations using the macs-tl system performed at a single facility between november 1999 and january 2000 are presented.Indications for treatment included patients with traumatic instabilities and fractures, old post-traumatic malpositions and spondylodicitis.The design of the mac-tl system incorporated stabilizations options from two partially fixed angle systems (a non-synthes plate and the synthes ventrofix system as a single rod system).The expandable titanium cage (synex) was used as vertebral body replacements.The average patient age was 40 years old, gender ratio (male/female) was 71:29.The macs-tl system was primarily implanted open 7 times and endoscopically 93 times.From among the first 100 implantations, 86 were performed to treat traumatic instabilities and fractures, of which 77% were classified as type a injuries, 17% were type b and 6% were type c.Of the type a injures 69% were exclusively ventral treatments with the fixed-angle implant compared to 2/3 of the cases that were treated through a combined dorsal-ventral approach.Two segments were fused in 60% of the cases and one segment was fused in 35% of the cases.For: 2 cases a bone screw had to be replaced due to intraoperative destructions of the titanium threading by a screw nut that placed in crooked position.This report is 4 of 4 for (b)(4).This report is for unknown nut, unknown quantity/ unknown lot number.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Upon further review of the complaint, it was determined the complaint is not reportable as the reported device is not manufactured by synthes.Synthes is retracting medwatch report # (2520274 - 2015 - 16893 ).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 5196055
• MDR Text Key: 30208013
• Report Number: 2520274-2015-16893
• Device Sequence Number: 1
• Product Code: KWP
• 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: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/12/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/03/2015
• 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