MAUDE Adverse Event Report: MEDTRONIC INFUSE; BONE GRAFT

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Dysphagia/ Odynophagia (1815); Incontinence (1928); Paresis (1998); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 05/11/2009

Event Type  Injury  

Event Description

(b)(6) 2009, pt under c5 corpectomy utilizing verte-stack anatomic peek ((b)(4)), two 11x14 x 8mm end caps part #6240841 joined by center strut 11x14x5mm part #6241041 forming a 21mm (h) by 11x14mm (l)x(d) cervical corpectomy construct.The cervical corpectomy construct was packed with rhbmp-2/sponge component of the infuse bone graft ((b)(4)).Pt developed progressive bi-lateral paresis both upper extremities and hands, incontinence, gait, dysphonia, dysphagia.Posterior laminectomy revision was performed (b)(6) 2013.

• Brand Name: INFUSE
• Type of Device: BONE GRAFT
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5267393
• MDR Text Key: 32756041
• Report Number: MW5058282
• Device Sequence Number: 4
• Product Code: NEK
• 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: 12/01/2015
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2015
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 50 YR
• Patient Weight: 76