MAUDE Adverse Event Report: SYNTHES (USA); IMPLANT, FIXATION DEVICE, SPINAL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article: cabrera, e., alejandro, l., (2011), preliminary clinical-radiologic results of kyphoplasty and vertebral stenting in the treatment of osteoporotic vertebral fracture, european spine journal, 20:2067-2095.Doi 10.1007/s00586-011-2013-1.The incidence of vertebral osteoporotic fractures is increasing.It is now the most common osteoporotic fracture and an important public health problem involving considerable healthcare cost.In this study, the preliminary clinical and radiologic results of kyphoplasty with vertebral stenting are reported a retrospective study of 31 patients with a lumbar or lower thoracic vertebral fracture at a single level with posterior wall integrity, treated by kyphoplasty with vertebral body stenting.Mean age was range was 69 through 87 years.Mean follow-up was 12 to 27 months.Complications that was reported are 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 reoperations were needed.There is not sufficient information to file multiple reports.Cement leakage.

Manufacturer Narrative

Cabrera, e., alejandro, l., (2011), preliminary clinical-radiologic results of kyphoplasty and vertebral stenting in the treatment of osteoporotic vertebral fracture, european spine journal, 20:2067¿2095.Doi 10.1007/s00586-011-2013-1.This report is for an unknown vertebral body stenting cement.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: IMPLANT, FIXATION DEVICE, SPINAL
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3761826
• MDR Text Key: 4487090
• Report Number: 2520274-2014-10925
• Device Sequence Number: 1
• Product Code: JDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention