MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for unknown (device name)/unknown quantity/unknown lot.Unknown part number, udi is unavailable.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 article: gradl, g.(2006).Combined stabilization of thoracolumbar spine fractures.European journal of trauma, vol.32, no.3, pp.289-252.Author: germany.The purpose of the study was to report the author¿s experience in dorso-ventral instrumentation of unstable spinal pathologies employing thoracoscopy, expandable cages or bone grafts as well as fixed-angle plates for anterior stabilization.In a prospective series from 2001 to 2005, operative technique of a combined dorso-ventral approach in the therapy of unstable thoraco-lumbar spinal pathologies was evaluated.Study included 89 patients (30 females, 59 males) with a mean age of 46.5 +/-20.6 years who sustained unstable fractures or tumor destruction of the thoraco-lumbar spine.Fracture care included primary dorsal stabilization by internal fixator system (synthes universal spine system (uss)).All patients received in a second step ventral corporectomy and vertebral body replacement by expandable titanium cages (non-synthes) or iliac crest bone graft (non-synthes).Complications: two cerebrospinal fluid leaks and five wound infections that required reoperation.The author did not specify the device the complications were associated with.Therefore, the complications will be reported.This is report 1 of 1 for (b)(4).This report is for an unknown uss.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• 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: 5404234
• MDR Text Key: 37303468
• Report Number: 2520274-2016-10634
• Device Sequence Number: 1
• Product Code: NKB
• 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: Health Professional
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2016
• 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?: Yes
• Date Manufacturer Received: 01/20/2016
• 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