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 Cyst(s) (1800); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

Literature citation: paul klimo, jr, and michael w.Peelle "use of polyetheretherketone spacer and recombinant human bone morphogenetic protein-2 in the cervical spine: a radiographic analysis" age- mean age is 53 years, (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 the literature titled ¿use of polyetheretherketone spacer and recombinant human bone morphogenetic protein-2 in the cervical spine: a radiographic analysis¿ that a radiological and clinical review of cervical fusions performed at the authors¿ in stitution with polyetheretherketone (peek) interbody cage and rhbmp-2 was undertaken.Perioperative clinical and radiologic data of all patients who underwent an anterior cervical discectomy and fusion using peek and rhbmp-2 for cervical spondylotic radiculopathy or myelopathy were collected.Images were examined for fusion, heterotopic ossification, end-plate resorption, subsidence, and segmental sagittal alignment.All patients underwent detailed postoperative radiologic analysis using a computed tomography (ct) scan obtained at least 6 months postoperatively and plain x-rays obtained at regular intervals twenty-two patients had 38 levels fused using peek and varying doses of rhbmp-2.No anterior cervical swelling requiring additional procedures or longer than anticipated hospital stays occurred.One patient returned to the emergency department on postoperative day 2 for concern of neck swelling without airway compromise.Pseudoarthrosis, shown as a horizontal radiolucent fissure through the midportion of the peek cage on ct, occurred in four patients.Excessive bone growth into the spinal canal or foramina occurred in 26 (68%) patients but did not result in neurologic sequelae.One patient suffered a recurrent laryngeal nerve palsy after a three-level fusion (c5¿t1) that recovered after 3 months.Cystic regions in the core of the peek spacer were seen in most patients, with 15 levels (39%) having cysts measuring 3 mm or greater.Our patient cohort demonstrated a high rate (68%) of heterotopic ossification, typically posterior to the peek cage and abutting the dural sac.Moderate or severe osteolysis of the end plates occurred in 57% of levels (20 out of 35 levels), and this led to subsidence of the construct and loss of some of the segmental sagittal alignment (ie, lordosis) that had been achieved with surgery.The fusion process using rhbmp-2 is a dynamic one, with osteolysis dominating the initial phase, leading to end-plate resorption and consequently loss of some of the disc space height and sagittal alignment that was achieved with surgery.There is a high incidence of bone growth beyond the core of the peek spacer and cystic regions within the cage.

• 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: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6766298
• MDR Text Key: 81777969
• Report Number: 1030489-2017-01860
• 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
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• 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: 07/10/2017
• 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): Other
• Patient Age: 53 YR