MAUDE Adverse Event Report: INTERBODY FIXATION LEGACY

Model Number 7510800

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Cyst(s) (1800); Debris, Bone Shedding (1803); Incontinence (1928); No Code Available (3191)

Event Date 08/30/2007

Event Type  Injury  

Event Description

Class iii medtronic infuse bone graft, approved under pma [p000058] implanted in combination with class ii intervertebral body fusion device medtronic hourglass cleared under (510(k)) [k033296] with class ii interbody fixation device medtronic legacy (510(k)) [k060203] was implanted into patient via posterior approach for multi-level lumbar fusion.Contrary to 21cfr888.3080 medtronic distributed into interstate commerce the combination of devices, components contrary to 21 cfr 888.3080 that requires such combination of class iii therapeutic biologic (bone morphogenic protein) and class ii intervertebral fusion device must have pma.In the absence of pma, the combination of components/device are adulterated and misbranded.Furthermore under 21 cfr 801.4 manufacture was required, upon knowledge of intended uses other than those for approved indications, being introduced into interstate commerce, must provide adequate labeling.In the absence of adequate labeling, the device(s) are misbranded.Patient developed post-operative complications including, but not limited to, lipoma, fluid-filled cyst(s), ectopic bone growth impinging on spinal nerves and loss of bladder control.Patient had revision (b)(6) 2013 surgery to remove lipoma.

• Brand Name: INTERBODY FIXATION LEGACY
• Type of Device: INTERBODY FIXATION
• MDR Report Key: 3885854
• MDR Text Key: 17997729
• Report Number: MW5036699
• Device Sequence Number: 3
• Product Code: MAX
• 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: 06/13/2014
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7510800
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention; Disability
• Patient Age: 36 YR
• Patient Weight: 62