MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SYNFLATE/VBS; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problems Pain (1994); Weakness (2145)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown vbs/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: alobaid, a., elsayed, i., and al-mutair, a.(2017), management of osteoporotic vertebral compression fractures with stenoplasty, orthopedics and rheumatology open access journal, vol.6, issue 2, pages, 1-7 (kuwait).The goals of this study were to determine the safety and effectiveness of vbs in improving vertebral body height, decreasing pain, and improving function.Between april 2012 and june 2015, a total of 52 patients (13 male and 39 female) with a mean age of 67 years (range, 49-89 years) were included in the study.These patients were treated with a vertebral body stents that are available in 2 sizes, {vertebral body stent (17mm [diameter] x 15 mm[length]) or (17mm [diameter] x 20 mm [length]), synthes (b)(4))} and pmma cement (vertecem, synthes).All outcomes were assessed before the procedure and at 1, 12, 24, and 36 weeks after the procedure.The following complications were reported as follows: 1 patient had a pulmonary embolism 7 days after vbs.This patient had a history of deep vein thrombosis (no evidence of pmma leakage to the lungs as indicated on ct angiography).1 patient was treated successfully with vbs on l2, l1 and t11.T12 was treated with conventional kyphoplasty in a prophylactic sense.The course was uneventful with mild pain.The follow-up x-rays showed a stable situation with no sintering of the reinforced bones and no loss of the initial reduction.1 patient had peri-operative confusion and generalized weakness that gradually resolved (per a negative brain ct and thorough neurologic exam).Acute recurrence of pain after 24 weeks; a fracture of the adjacent levels l2, l1 and t11 was observed (arrows) on the x-ray and mri.L and m the patient was treated successfully with vbs on l2, l1 and t11.T12 was treated with conventional kyphoplasty in a prophylactic sense.The course was uneventful with mild pain.Evaluation of intra- and postoperative radiographs revealed extra-vertebral cement leaks in 23 of the 73 vertebral fractures treated.In 5 cases, cement leaked into the adjacent intervertebral disc.In six cases, leakage occurred anterior to the vertebral body; in three patients, cement leaked both into the adjacent intervertebral disc and anterior to the vertebra.All polymethylmethacrylate extravasations were asymptomatic.The cement remained in the immediate area of the treated vertebrae, and no medical or surgical intervention was required to remove the extravasated polymethylmethacrylate.The overall reoccurrence rate was 3 out of 48 patients who completed the 9 month follow-up.This report is for an unknown synthes vbs.It captures the reported weakness and recurrence of pain.This is report 2 of 3 for complaint (b)(4).

• Brand Name: UNK - SYNFLATE/VBS
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9120765
• MDR Text Key: 165039570
• Report Number: 8030965-2019-68709
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: KU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• 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?: Yes
• Date Manufacturer Received: 08/30/2019
• 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