MAUDE Adverse Event Report: OSTEOTECH GRAFTON

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Pain (1994); Dysphasia (2195); Disability (2371)

Event Date 02/29/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, i underwent c5, c6 cervical interbody fusion performed by dr (b)(6).Devices utilized include: amedica valeo cervical cage (2) packed with (in combination with) osteotech grafton putty.Valeo is only cleared for one-level cervical interbody fusion.Grafton not approved or cleared to be use for intended uses in cervical spine or for indications requiring load bearing, stability of boney structures.The surgeon, dr (b)(6) failed to disclose that devices would be used in manner not approved or cleared by fda or that he had financial ties to medtronic, parent company of osteotech.Post-op complications include but not limited to, worsening of pre-op symptoms, dysphagia, dysphonia, tumor and boney overgrowth.Revision posterior cervical fusion performed on (b)(6) 2014 by dr (b)(6), who also did not disclose conflict with medtronic.I am rendered fully disabled and in constant pain.Have been recommended for spinal stimulator implant.

• Brand Name: GRAFTON
• Type of Device: GRAFTON
• Manufacturer (Section D): OSTEOTECH
• MDR Report Key: 4466466
• MDR Text Key: 5397640
• Report Number: MW5040477
• Device Sequence Number: 1
• Product Code: MBP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 73