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 Edema (1820); Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Literature citation: andrew young, adam mirarchi, "soft tissue swelling associated with the use of recombinant human bone morphogenetic protein-2 in long bone non-unions." (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.

Event Description

It was reported in an abstract titled soft tissue swelling associated with the use of recombinant human bone morphogenetic protein-2 in long bone non-unions that patient sustained a right diaphyseal humeral shaft fracture that was initially treated with intramedullary nail fixation using a deltopectoral splitting approach.Eight months after her index surgery, she complained of instability and pain at the fracture site.Radiographs revealed an atrophic-appearing nonunion.She underwent intramedullary nail removal, debridement of the fracture site and compression plating of her fracture non-union using a combined deltopectoral and anterolateral approach.A small rhbmp-2 sponge was placed alongside the fracture site.She was seen in the outpatient clinic on post-operative day 7 and noted to have a large erythematous and edematous region centered over the incision.She was started on a short course of oral antibiotics.Radiographs at her initial follow-up did not show any loss of fixation or hardware failure.She was seen in the outpatient clinic on post-operative day 9 with continued complaints of significant swelling and pain in her arm.There was now gross motion noted at her fracture site and radiographs demonstrated loss of fixation with pullout of the distal screws.The swelling and erythema appeared to be out of proportion to that which would be expected with loss of fixation.The patient returned to the operating room for revision fixation and debridement for suspected deep postoperative surgical site infection.Intraoperative findings were not consistent with infection.Considerable woody edema was found within the biceps and brachioradialis muscle bellies, centered over the bmp sponge.She underwent revision internal fixation and removal of the rhbmp-2 sponge.

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: 5892818
• MDR Text Key: 52609214
• Report Number: 1030489-2016-02392
• 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,Followup
• Report Date: 07/27/2016

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?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/22/2016
• Supplement Dates Manufacturer Received: 07/27/2016
• Supplement Dates FDA Received: 09/24/2017
• 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: 61 YR