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

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

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Literature citation: author(s): mohamed macki, md, sbaa syeda, bs, kenan rajjoub, ba, panagiotis kerezoudis, md, ali bydon, md, jean-paul wolinsky, md, timothy witham, md, daniel m.Sciubba, md, mohamad bydon, md, ziya gokaslan, md " the effect of smoking status on successful arthrodesis after lumbar instrumentation supplemented with rhbmp-2." gender: 17 males and 11 females.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.

Event Description

It was reported by in a publication titled "the effect of smoking status on successful arthrodesis after lumbar instrumentation supplemented with rhbmp-2 ", the primary objective of this study is to examine the effects smoking status on rhbmp-2 supplementation in spinal fusion constructs.The study was carried out with respect to two groups, smokers (82 patients) and non-smokers (28).All operations included arthrodesis supplementation with rhbmp-2.Fusions with greater than 1 interbody cages as well as fusions in the anterior approach were excluded.Pediatric cases were also not examined.Post-op, out of the 28 patients, 2 patients reported wound infection.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6112003
• MDR Text Key: 60281788
• Report Number: 1030489-2016-03186
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR