MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Hematoma (1884); Inflammation (1932); Pain (1994)
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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