MAUDE Adverse Event Report: DEPUY SYNTHES SPINE KANEDA ROD; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problems Pain (1994); No Code Available (3191)

Event Type  Injury  

Event Description

Post market surveillance review of literature found a report of a patient who had undergone a 2-level thoracic corpectomy and standalone anterior thoracic fusion with kaneda screw-rod stabilization who developed back pain at 6 months after the index surgical procedure related to instability at the site of a failed fusion and subsequently required a posterior revision surgery with instrumentation.Article title: 'stackable carbon fiber cages for thoracolumbar interbody fusion after corpectomy: long-term outcome analysis' publication date: mar 2011.Unknown stackable cage used.N=1: kaneda (rod & screw) failed to maintain stability of construct quantity of rods and screws are unknown.The following mfg.Medwatch reports are being filed for the kaneda rod(s) and screw(s) involved in the reported instability: 1526439-2014-12229.

Manufacturer Narrative

This complaint was generated from literature review conducted in post market surveillance (pms) for health authority reporting purposes.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the pms identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Not returned.

• Brand Name: KANEDA ROD
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 4336067
• MDR Text Key: 5249202
• Report Number: 1526439-2014-12228
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Type of Report: Initial
• Report Date: 11/21/2014

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: Physician
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention