|
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.
|
|
Search Alerts/Recalls
|
|
|