MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK 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 Ossification (1428)

Event Type  Injury  

Manufacturer Narrative

Occupation: patient although it is unknown if the device contributed to the event, we are filing this report for notification purposes.Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in a social media post that the patient underwent an unspecified fusion surgery on an unknown date using rhbmp-2.Post-op, patient allegedly suffered with uncontrolled bone growth and cancer.Patient had undergone 3 unknown surgeries.No other info was available.

Manufacturer Narrative

Post-op x-rays for l3-s1, posterolateral fusion.A single lateral view shows interbody grafts of l3-4, l4-5 and appropriate hardware placement.The interbody grafts to not appear completely ossified.Unable to assess lateral/ foraminal hyperostosis or the presence of any mass lesion on provided images.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; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7841124
• MDR Text Key: 119021411
• Report Number: 1030489-2018-01198
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/13/2018

1 Device was Involved in the Event

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/12/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 09/13/2018
• 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; Required Intervention