MAUDE Adverse Event Report: SYNTHES USA; DISPENSER, CEMENT

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.Scola, a; gebhard, f; schultheiss, m (2010) 5 deutscher wirbelsaulenkongress abstract ¿ article p87; preliminary clinical results with vertebral body stenting.Eur spine j.19:1963-2073.This report is for an unknown vertebral body stenting (unknown quantity/unknown lot).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.(b)(4).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: scola, a; gebhard, f; schultheiss, m (2010) 5 deutscher wirbelsaulenkongress abstract ¿ article p87; preliminary clinical results with vertebral body stenting.Eur spine j.19:1963-2073.This is a retrospective biomechanical study to show an enhanced reposition of the fracture compared to conventional kyphoplasty.A total of 57 vertebral bodies (19 thoracal, 38 lumbal, th6 till l4) in 53 patients (31 women, 22 men, average age 76,2 ±8,9 years) were operated using vertebral body stenting vbs system manufactured by synthes.Forty-five (45) patients had an osteoporotic and 8 patients a pathological fracture.The implantation of the vertebral body stent was possible in all cases.The average height gain in the middle of the vertebral body was 0.27 cm (sd±0.16), anterior 0.26 cm (sd±0.16).The percentage gain in the middle was 21% (sd±16.3), anterior 15,3% (sd±13,3).In one case the stent could not be dilated on one side due to a sclerotic area.In another case the lateral wall of the vertebral body was fractured while dilating the stent.This was not recognized during the operation.There have been no postoperative neurologic problems.The results show that using the vertebral body stenting system a good fracture reposition can be achieved.It is a save system with few complications.This is 1 of 2 for (b)(4).This report is for an unknown vertebral body stenting and refers to the serious injury of 1 unknown patient who experienced the stent could not be dilated on one side due to sclerotic area.

• 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: 6774010
• MDR Text Key: 82056036
• Report Number: 2520274-2017-12057
• 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