MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; CEMENT, BONE, VERTEBROPLASTY

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Embolism (1829)

Event Type  Injury  

Event Description

It was reported in a post-market study trial that patients with osteoporosis with 1¿3 acute fractures (t5¿l5) were randomized and treated with kyphoplasty (n=191) or vertebroplasty (n=190).The average age of patients was 75.6 years (77.4% female).Tools and polymethylmethacrylate bone cement used were approved or cleared by the fda for treating vcfs by using bkp and vp, respectively.Bkp was performed by using a bilateral approach.It was reported that 1 out of 191 patients presented with a cement embolism (bone cement-related).In this case, the event occurred after the surgical treatment of a subsequent fracture and was resolved with oxygen.

Manufacturer Narrative

Literature citation: m.Dohm, c.M.Black, a.Dacre, j.B.Tillman, g.Fueredi."a randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis".Ajnr am j neuroradiol: 2014; 10.3174/ajnr.A4127.A2.Average age = 75.6 years a3.77.4% female; 22.6% 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.

• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: huzefa mamoola ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 4583711
• MDR Text Key: 18932682
• Report Number: 1030489-2015-00479
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2014
• 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
• Treatment: BKP
• Patient Outcome(s): Required Intervention
• Patient Age: 00076 YR