MAUDE Adverse Event Report: MEDTRONICS INFUSE WITH CAGE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cyst(s) (1800); Pain (1994); Seroma (2069); Patient Problem/Medical Problem (2688)

Event Date 10/01/2010

Event Type  Injury  

Event Description

Off-label/not fda approved/not disclosed to patient 2 lumbar level use (l2-3 and l3-4) of infuse by orthopedic spine surgeon, (b)(6), in (b)(6) 2010.Periodic but progressive low back pain and left sciatica symptoms reportedly requiring extension of fusion on (b)(6) 2017 by same surgeon.This time osteoamp putty was used along the length of t10 to l3/4 fusion.Subsequent left s1 and right t10 radiculopathies starting at 1-2 weeks post op and persisting at approximately 2.5 months now have been incapacitating and requiring second surgery to be arranged to remove large left s1-2 cyst thought related to infuse from 2010 and/or from osteoamp used during the (b)(6) 2017 surgery.Additionally a large septated and rimmed seroma from approximately t10 to l3/4 that is thought to be subacute to chronic has been noted on scans since the (b)(6) 2017 surgery, with radiologists and surgeons differing in opinion an estimated age.Very concerned about progressive vs persistent severe radiculopathy pain and neurologic dysfunction over time.Evidence of subacute to chronic impact on l5 and s1 is seen on recent emg.Unclear per physicians whether it is related to underlying degenerative disc disease, known large s1 facet joint cyst, or related to inflammatory response from bone morphogenetic protein use.Dose or amount: 2 disc infusions.Frequency: at spinal surgery.Route: injected into spinal area.Diagnosis or reason for use: implanted by surgeon to promote lumbar fusion.Is the product compounded: no.Is the product over the counter: no.

• Brand Name: INFUSE WITH CAGE
• Type of Device: INFUSE WITH CAGE
• Manufacturer (Section D): MEDTRONICS
• MDR Report Key: 6489374
• MDR Text Key: 72839317
• Report Number: MW5069057
• Device Sequence Number: 1
• Product Code: NEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: AMBIEN. ; DILAUDID; MONTULEKAST; OTC MEDS: VITAMIN C ; RX MEDS: LISINOPRIL; SYNTHROID; TYLENOL.; VITAMIN D; XANAX; ZOLOFT; ZYRTEC
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 73 YR
• Patient Weight: 73