MAUDE Adverse Event Report: SYNTHES USA; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 12/02/2015

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not for diagnosis.This report is for an unknown vertecem v (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.(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: behrbalk, e; et al (2016) staged correction of severe thoracic kyphosis in patients with multilevel osteoporotic vertebral compression fractures.Global spine journal, vol 6: no 7, 710-720.Multilevel osteoporotic vertebral compression fractures may lead to considerable thoracic deformity and sagittal imbalance, which may necessitate surgical intervention.Correction of advanced thoracic kyphosis in patients with severe osteoporosis remains challenging, with a high rate of failure.This is a retrospective study of surgical techniques of 5 patients (two women and three men, average age 62 + 6 years) with multilevel osteoporotic vertebral compression fractures and severe symptomatic thoracic kyphosis underwent staged vertebral augmentation and surgical correction of their sagittal deformity using a minimum of 4 ml polymethyl methacrylate bone cement (vertecem v, depuy-synthes, (b)(4)) injected into each vertebra.One patient ((b)(6)) had transient hypotension during cement injection into the t12 vertebra (second-stage procedure), which was the last vertebra injected in this stage that resolved spontaneously.Postoperatively, no clinical evidence of fat emboli was observed.In another patient ((b)(6)), intraoperative fluoroscopy showed cement leakage into the segmental veins during cement injection of the l2 vertebrae.The postoperative computed tomography angiography showed no evidence of cement embolus in the lungs.No neurologic complications or hardware failure occurred in any of the patients.No case of cortical screw breach was found on follow-up radiographs.This 1 of 2 for (b)(4).This report is for an unknown vertecem v and refers to the serious injury / reportable malfunction of (b)(6) male who experienced cement leakage in segmental veins.

• Type of Device: POLYMETHYLMETHACRYLATE BONE 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: 6744887
• MDR Text Key: 81078010
• Report Number: 2520274-2017-11987
• Device Sequence Number: 1
• Product Code: NDN
• 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: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2017
• 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
• Patient Age: 56 YR