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 Unspecified Infection (1930); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Literature citation: norbert stiel, tim n.Hissnauer, martin rupprecht, kornelia babin, carsten w.Schlickewei, johannes m.Rueger, ralf stuecker, alexander s.Spiro, "evaluation of complications associated with off-label use of recombinant human bone morphogenetic protein-2 (rhbmp-2) in pediatric orthopaedics".Average age: 10.9 years; gender: 16 female, 23 male.(b)(4).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.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.

Event Description

It was reported in a abstract "evaluation of complications associated with off-label use of recombinant human bone morphogenetic protein-2 (rhbmp-2) in pediatric orthopedics" that 39 patients underwent following procedures using rhbmp-2/acs: 17 patients underwent spine fusion (thoracolumbal = 9 cases; craniocervical = 5 cases; other locations = 3 cases), 11 patients underwent treatment of congenital pseudarthrosis of the tibia (7 cases) or tibial nonunion (4 cases), 5 patients underwent the management of femoral nonunion, 5 patients underwent nonunions at other locations, like the ulna (1 case), os ilium (2 cases), ankle joint (1 case), and talonavicular joint (1 case), and in 1 case for tibial shortening.Intraoperative complications were not reported.Post-op infection was reported in one case and patient underwent revision surgery.

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: 6180001
• MDR Text Key: 62521451
• Report Number: 1030489-2016-03434
• Device Sequence Number: 1
• Product Code: NEK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• 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: 11/22/2016
• 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: 10 YR