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

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

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported in a literature article which compared the results of treating nonunion with either bone morphogenetic protein (bmp)-7 or bmp-2, that between 2001 and 2009, 214 limb segments were treated for nonunion with either bmp-7 or bmp-2.One hundred thirty eight limb segments (112 patients) received bmp-2.There were 45 tibiae, 43 femora, and 50 humeri treated.Eighty-eight percent (121 of 138 limb segments) received autograft and bmp-2, and 12% received bmp-2 only (14 limb segments) or allograft plus bmp-2 (3 limb segments).Twenty-nine percent of limb segments (40 of 138) were treated with an adjunctive external bone growth stimulator.Patients who had the bone stimulator were encouraged to use it as soon as they received it.Radiographic healing occurred in 129 (93%) of 138 limb segments at an average of 19 weeks (range, 2-53) after surgery.Eighty-eight percent of limb segments (122 of 138) were full weight bearing (clinically healed) at the completion of the study.The average time to weight bearing was 15 weeks (range, 0-53) after surgery.The average time to weight bearing was 15 weeks (range, 0-53) after surgery.The average followup was 17 months (range, 3-56).Thirty-two subjects, across both groups, had more than 1 surgical procedure for bone grafting.Seven patients (7 limb segments) received both bmp-7 and bmp-2 in the same limb segment during different surgical procedures.These 7 patients underwent treatment with bmp-7 and did not heal.They underwent treatment with bmp-2 at an average of 22 months (range, 6-57) after the initial treatment with bmp-7.After treatment with bmp-2, all patients healed at an average of 18 weeks (range, 10-22).The complication rate in the bmp-2 group was lower (9%) than in the bmp-7 group (17%).One patient in the bmp-2 group required additional surgery for malalignment.

Manufacturer Narrative

Literature citation: conway et al.¿bmp-7 versus bmp-2 for the treatment of long bone nonunion¿.Orthopedics.2014; 37(12):e1049-e1057.(b)(4).Neither the device nor patient medical records were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted/used during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.

• Brand Name: INFUSE BONE GRAFT
• Type of Device: FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD, OSTEOIN
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4382777
• MDR Text Key: 5260192
• Report Number: 1030489-2015-00021
• Device Sequence Number: 1
• Product Code: MPW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• 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: 12/06/2014
• 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): Required Intervention
• Patient Age: 00037 YR