MAUDE Adverse Event Report: SYNTHES USA; DISPENSER, CEMENT

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

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Cabrera e; et al (2011) geer abstract- article #20 ¿ preliminary clinical radiologic results of kyphoplasty and vertebral stenting in the treatment of osteoporotic vertebral fractures.Eur spine j, 20: 2067-2095.This report is for an unknown vertebral body stenting (unknown quantity/unknown lot).(other number) udi: unknown part number, udi is unavailable.The investigation could not be completed; no conclusion could be drawn, as no device was returned and no lot number or part number was provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after subsequent review of the following literature article: cabrera e; et al (2011) geer abstract- article #20 ¿ preliminary clinical radiologic results of kyphoplasty and vertebral stenting in the treatment of osteoporotic vertebral fractures.Eur spine j, 20: 2067-2095.This is a retrospective study of 31 patients with a lumbar or lower thoracic (d9¿12) vertebral fracture at a single level with posterior wall integrity, treated by kyphoplasty with vertebral body stenting (vbs, synthes).Mean age was 77.6 years (69¿87 years).Mean follow-up was 19 months (12¿ 27 months).The mean postoperative hospital stay was 24 h (24¿72 h).At 1-year follow-up, there was no loss of the height attained.Three cases of asymptomatic cement leak occurred, and two cases of vertebral fracture in segments adjacent to the treated vertebra.There were no infections or complications.No re-operations were needed.Kyphoplasty with vertebral stenting is a safe, useful method for treating osteoporotic fractures that achieves a significant reduction in pain and analgesic requirements.Our series showed acceptable restoration of vertebral height and partial correction of sagittal alignment.This is 2 of 2 for (b)(4).This report is for an unknown vertebral body stenting and refers to the serious injury of 2 cases of vertebral fracture.

• Type of Device: DISPENSER, CEMENT
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6773897
• MDR Text Key: 82049703
• Report Number: 2520274-2017-12060
• Device Sequence Number: 1
• Product Code: KIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• 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?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention