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

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

Patient Problems Pain (1994); Skin Irritation (2076); Burning Sensation (2146)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable medical records or imaging studies were returned nor provided for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post-op, the patient was experiencing high levels of irritation, burning and scratching sensation all over the skin around associated wound area.Irritation goes from uncomfortable to highly painful, to quote the patient "makes me want to pull my skin off".Irritation has been present ever since the operative date.

• Brand Name: INDUCTOS
• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7323615
• MDR Text Key: 101867571
• Report Number: 1030489-2018-00345
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/08/2018

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2018
• Initial Date FDA Received: 03/08/2018
• 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