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); Hematoma (1884); Inflammation (1932); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Literature citation: andrew young, adam mirarch; ¿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 that patient sustained a left diaphyseal femoral shaft fracture in a roll-over motor vehicle accident initially treated with operative fixation using an intramedullary nail, which subsequently loosened distally.Patient reported thigh pain localized to the surgical site.The patient underwent reamed exchange retrograde femoral nailing of his non-union fracture along with open debridement of the fracture site and placement of a large-size rhbmp-2 sponge with cancellous bone allograft.Post-operatively patient developed acute local soft tissue inflammation.On post-operative day 1 the patient complained of increasing pressure and pain in the left thigh.Patient returned to the operating room urgently for hematoma evacuation and the skin overlying the operative area was noted to be edematous and thickened.Patient presented emergently 5 days later with increased thigh pain and pressure.Repeat operative debridement of all non-viable tissue (primarily vastus lateralis muscle) and extensive lateral thigh fasciotomy were performed due to elevated intraoperative compartmental pressure measurements (anterior thigh systolic compartment pressures of 95 mmhg, diastolic pressures were 70 mmhg on average).The large rhbmp-2 sponge was removed.Vastus lateralis muscle biopsy specimens were obtained revealing ischemic changes with granulation tissue.There was no evidence of acute post-operative infection, and all intraoperative cultures were negative.The patient ultimately required a split thickness skin graft at the fasciotomy site for definitive soft t issue coverage.Seven months after the non-union repair procedure, radiographs revealed persistent fracture non-union with exuberant ectopic bone in the thigh musculature.

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: 5892827
• MDR Text Key: 52609271
• Report Number: 1030489-2016-02396
• 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

• Date FDA Received: 08/22/2016
• 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: 07/27/2016
• 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: 25 YR