GRAFTON

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-21 for GRAFTON manufactured by Osteotech.

Event Text Entries

[5397640] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5040477
• MDR Report Key: 4466466
• Date Received: 2015-01-21
• Date of Report: 2015-01-21
• Date of Event: 2012-02-29
• Date Added to Maude: 2015-01-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PATIENT
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: GRAFTON
• Generic Name: GRAFTON
• Product Code: MBP
• Date Received: 2015-01-21
• Operator: HEALTH PROFESSIONAL
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: OSTEOTECH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit	2015-01-21