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

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint #:(b)(4).This report is for an unk - biomaterial - cement: vertecem v+/unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: wang m., et al (2021) selections of bone cement viscosity and volume in percutaneous vertebroplasty: a retrospective cohort study, world neurosurgery volume xxxxx, pages e1-e10 (china) this retrospective cohort study aims to evaluate and compare the efficacy and complications of different injection volumes and viscosities of bone cement during pvp for the treatment of single thoracolumbar level ovcfs to provide a theoretical and clinical reference for selecting the optimal injection volume of different viscosities of bone cement.From january 2014 to december 2019, clinical data of elderly patients with single thoracolumbar level (t12-l2) osteoporotic fractures treated with pvp were analyzed in the study.A total of 307 cases were included in the study.The patients were divided into 6 groups according to the different viscosities (i: low-viscosity bone cement group, with 51 patients for group a (11 males,40 females), 43 patients for group b (11 males,32 females) and 53 patients for group c (13 males and 40 females) where bone cement mendec (tecres s.P.A) was used while in group ii: high-viscosity bone cement: 63 patients in group a (15 males,48 females), 48 patients in group b (10 males and 38 females), and 49 patients in group c (12 males, 37 females) and injection volumes (a, 2-4 ml; b, 4-6 ml; c, 6-8 ml) where bone cement vertecem v+ (synthes gmbh).The following complications were reported: at the last follow-up, the avhr and lka in all 6 groups showed deterioration.Group a, some patients still had obvious pain.A case of a (b)(6) male at the last follow-up, the avhr and lka showed deterioration.A case of a (b)(6) female at the last follow-up, the avhr and lka showed deterioration.A case of a (b)(6) female at the last follow-up, the avhr and lka showed deterioration.Cement leakage: group iia: 21, group iib:17 and group iic 20.Cemented vertebral body re-collapse: group iia: 12, group iib:2.This report is for an unknown synthes bone cement vertecem v+.This report is for (1) unk - biomaterial - cement: vertecem v+ this report is 1 of 6 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: VERTECEM V+
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11897873
• MDR Text Key: 266602945
• Report Number: 8030965-2021-04394
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• 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?: Yes
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention