MAUDE Adverse Event Report: MEDTRONIC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

Model Number 510400 IP

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Paresthesia (4421)

Event Type  Injury  

Event Description

Please be informed that synthes received a potential adverse event on (b)(6) 2009 regarding a non-synthes product: medtronic bone kit infuse medium/510400 ip the following incident was reported to synthes and logged as complaint com-073461.Patient was found to have discogenic disease at l3-4, l4-5 and ls-s1 and disc herniation to the right at l4-5.On (b)(6) 2008 patient had a total disc arthroplasty at l3-4 levels using synthes prodisc.L, anterior lumbar interbody fusion at l4-s 1, and l5-s i using synthes anterior instrumentation and synthetic cage with medtronic bone kit infuse morphogenic protein.Initially patient did very well and then after six months he began to decline with increasing back, hip, leg pain and paresthesias.Patient was revised to pedicle screw and rod instrumentation using pangaea system at l4-s1 levels with unknown bone protein.Surgeon also performed a decompressive laminectomy with extensive foraminotomies at l4, l5, and s1 for central and foraminal decompression.(b)(4) this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17532455
• MDR Text Key: 321132677
• Report Number: MW5139363
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 510400 IP
• Patient Sequence Number: 1