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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bone Fracture(s) (1870); Myocardial Infarction (1969); Pain (1994); Pneumonia (2011)

Event Type  Injury  

Manufacturer Narrative

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.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.

Event Description

Total patients involved: 350 (78% female, 22% male, average age: 78.9 years) it was reported in the literature titled ¿prospective and multi center evaluation of outcomes for quality of life and activities of daily living for balloon kyphoplasty in the treatment of vertebral compression fractures:the evolve trial" that a total of 354 patients with painful vertebral compression fractures were enrolled with 350 patients who underwent kyphoplasty.The most common serious adverse events (saes) within 30 days of surgery were back pain (14/350 or 4.0%) and new symptomatic fracture (5/350 or 1.4%).These were also the most common sae categories over 1 year of follow-up: back pain (17/350 or 4.9%) and new symptomatic fracture (16/350 or 4.6%).Five adverse events that were possibly device or procedure-related included an asymptomatic balloon rupture considered cement related and another subject with rib pain considered possibly cement-related that began intra-operatively and resolved within 6 months; another subject had a new adjacent vcf ae 25 days post-procedure considered possibly cement-related.None of these patients with cement-related aes were reported to have any cement leakage.One subject experienced an sae of aspiration pneumonia, considered possibly related to anesthesia that occurred at the end of the procedure, prolonging hospital stay.Another subject with a baseline history of coronary artery disease and prior myocardial infarction had a myocardial infarction sae 105 days post procedure that was thought possibly related to procedure/anesthesia; symptoms resolved within 2 days with pharmaceutical therapy.In conclusion, significantly reduced pain and disability, improved function, ambulatory status, self-care abilities, and quality of life following kyphoplasty were observed.Narcotic medications usage was reduced, as were days of bed rest and limited activity.There was statistically significant vertebral deformity correction.Five device/procedure-related aes were reported;symptoms of each resolved with appropriate treatment.All cases of cement extravasation were asymptomatic.The rate of new and/or adjacent vertebral fractures after kyphoplasty was relatively high and likely attributed to fracture risk factors such as an older patient population, multiple prevalent vcfs, and less osteoporosis treatment.Improvements in pain, function, and quality of life are prompt and sustained indicating that bkp is rapidly effective and durable upto 1year.Statistical significance was attained for all primary endpoints and at all time points.These results support the use of kyphoplasty as a safe and highly effective treatment for painful, acute vertebral body compression fractures in patients commonly referred for treatment with an excellent risk:benefit profile.Three hundred fifty-four subjects were enrolled; 4 subjects withdrew prior to receiving treatment; within the 350 subjects treated, 7 subjects were included who had deviations to the inclusion/exclusion criteria (1 was not medicare eligible; 1 had a fracture age slightly >4 months, 4 had nrs scores<(><<)> 7, and 1 was participating in another clinical study).Forty-nine patients voluntarily withdrew prior to the 12-month assessment, 15 were lost to follow-up, and 26 deaths occurred from causes unrelated to treatment.One patient who terminated the study early experienced an ae (a decline in general health leading to hospice care), precluding continued participation.Two hundred sixty patients completed the study.

• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC.; 1800 pyramid place; memphis TN 38132
• Manufacturer Contact: stacie ziemba ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 8763947
• MDR Text Key: 150121498
• Report Number: 1030489-2019-00718
• 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: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2019

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: 06/07/2019
• Initial Date FDA Received: 07/05/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR