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 Problems Failure of Implant (1924); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Literature citation: lisa k.Cannada, md (st.Louis university hospital), paul tornetta iii, md (boston medical center), william t.Obremskey, md (vanderbilt university medical center), ellen j.Mackenzie, phd (mcc jhsph), daniel o.Scharfstein (mcc jhsph), lisa reider, phd (mcc jhsph), jason luly, ms (mcc jhsph), greg de lissovoy, phd (mcc jhsph); ¿a randomized controlled trial comparing bone morphogenic protein vs autograft for the treatment of tibia fractures with critical size defects¿ average age at time of first exposure: (b)(6) years.Sex: 12 no.Of males.Neither the device nor applicable imaging films were returned to manufacturer for evaluation therefore we are unable to determine the definitive cause of event.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in the literature titled ¿a randomized controlled trial comparing bone morphogenic protein vs autograft for the treatment of tibia fractures with critical size defects¿ that a study was conducted of five patients in the rhbmp2 group were readmitted for post-grafting treatment compared with 3 in the icbg group (p=0.69).Three patients in the rhbmp-2 group had an infection vs.None in the icbg group (p=0.23).One patient experienced a deep surgical site infection diagnosed as osteomyelitis approximately 12 weeks after grafting surgery.Two patients were operatively treated for a post grafting non-union, 1 rhbmp-2 and 1 icbg patient.Both patients were treated for the non-union 8 months following bone grafting.Another patient in the rhbmp group had hardware removed approximately 3 months following the grafting procedure and coincided with multiple treatments for infection.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 7319744
• MDR Text Key: 101691961
• Report Number: 1030489-2018-00325
• 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
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• 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: 02/08/2018
• 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
• Patient Age: 37 YR