MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - BIOMATERIAL - CEMENT: VERTECEM V+; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number UNK - BIOMATERIAL - CEMENT: VE

Device Problem Fluid/Blood Leak (1250)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 08/15/2015

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown biomaterial - cement: vertecem v+/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.Investigation summary 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, 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: hoppe s., et al (2016),lavage prior to vertebral augmentation reduces the risk for cement leakage, european spine journal volume 25 (11), pages 3463¿3469 (switzerland).This study aims to assess radiologically the filling patterns of the cement and the cement leakage rates in patients treated with vp, kp or stenoplasty (sp) with and without lavage.From january 2012 to august 2014, a total of 142 consecutive patients with osteoporotic vcf who were treated were included in the study.The newly developed lavage technique was applied prior to cement application in 64 patients with 116 vertebrae.These were assigned to the interventional ¿¿lavage¿¿ group.A conventional cement injection technique was used to treat 78 patients with 99 vertebrae, who were assigned to ¿¿controls¿¿ group.Three types of vertebral augmentation were used: vp, kp and sp.In the kyphoplasty group a standard kyphoplasty device (synflate¿vertebral balloon system, synthes (b)(4)), for the stenoplasty a standard stenoplasty device (vbs¿vertebral body stenting system, synthes, bettlach, switzerland) and cement preparation was performed according to the manufacturer¿s manual (vertecem v+,synthes, (b)(4)).The following complications were reported as follows: vertebrae with a leakage: overall 44 in lavage group, 83 in control group.Vertebrae with a leakage: venous 15 in lavage group, 31 in the control group.Vertebrae with a leakage: cortical defect 20 in lavage group 63 in the control group.Vertebrae with a leakage: intradiscal 14 in lavage group 15 0.51 in the control group.The extent of leakage, overall: 27 in lavage group 36 0.1 in the control group.Extent of leakage, overall: 2¿10 mm 14 in lavage group, 40 in control group.Extent of leakage, overall: 10 mm 2 in lavage group 7 in control group.This report is for an unknown synthes synflate¿vertebral balloon system, standard stenoplasty, vbs¿vertebral body stenting system and vertecem v+.This report is for one (1) unk - biomaterial - cement: vertecem v+.This report is 1 of 1 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: VERTECEM V+
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 9520485
• MDR Text Key: 189054030
• Report Number: 8030965-2019-71475
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - BIOMATERIAL - CEMENT: VE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• 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