MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK; ARTHROSCOPE

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported in a journal article that 46 balloon kyphoplasty procedures (bkp) were performed in 43 patients with unhealed vcfs ( vertebral compression fractures) over a 21 month period.Bkp was performed in patients (whose pain was caused by vcf) was not relieved after adequate conservative treatment, such as the administration of appropriate analgesic drugs, bracing, and bed rest.Preoperative instability was defined as a change in vertebral shape on lateral x-ray films obtained in both the sitting and supine positions.If a vertebra exhibited instability, the vertebra was diagnosed as the source of pain.All treated cases of vcf were attributed etiologically to osteoporosis, not myeloma or metastatic spinal tumors.Bkp was performed under general anesthesia for one vertebra in each surgery.Two bone tamps/balloons were inserted into the vertebral body under image guidance using a bilateral approach.The balloons were inflated to expand the vertebral body to create a cavity and reduce the fracture deformity.After completing these procedures, the balloons were deflated and removed, and the cavity was filled with cement at an appropriate level of viscosity until the cement touched the end plate under image guidance.Thirty-eight of the 46 vertebrae that were evaluated on lateral roentgenkymography within 1 week after bkp were assessed.Fracture types were categorized into wedge, crush, and biconcave.Wedge-type fracture occurred in 31 cases, crush-type fracture in one case, and biconcave-type fracture in six cases.Bkp was performed at t7-t10 in three cases, t11-l2 in 32 cases, and l3-5 in three cases.The average duration from the onset of pain to surgery was 6 months (0.5 to 29 months).Postoperative instability was defined as the following two points using lateral x-ray films obtained in both the sitting and supine position.First, a cleft was observed between the cement and end plate of the vertebra in the supine position that disappeared in the sitting position.Second, the posterior wall height of the vertebra was reduced in the sitting position.Strong fixation immediately after bkp was not achieved in a total of 17 vertebrae.There was no difference in the incidence of instability by vertebral fracture type.The vas scores improved in all cases, regardless of the presence of instability.It was reported that "one case of surgical site infection occurred and was successfully treated with antibiotics".

Manufacturer Narrative

Literature citation : kiyoshi tarukado, et al."instability of the vertebrae remains following balloon kyphoplasty".Global spine j 2014; 4: 89-92.(b)(4).

• Type of Device: ARTHROSCOPE
• 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: 3981837
• MDR Text Key: 20107871
• Report Number: 2953769-2014-00104
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2014

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: 07/07/2014
• Initial Date FDA Received: 08/05/2014
• 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: IBTS, CEMENT
• Patient Outcome(s): Required Intervention
• Patient Age: 00081 YR