MAUDE Adverse Event Report: SYNTHES GMBH SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 07.702.016S

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint #(b)(4).(510k): unknown, as specific lot numbers are unknown; device is not distributed in the united states, but is similar to device marketed in the usa.Complainant device is not expected to be returned for manufacturer review/investigation.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 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 europe reports an event in (b)(6) as follows: it was reported that this was a vertebroplasty at l1 treating vertebral fracture on (b)(6), 2021.The surgeon selected an out-of-vertebrae route, he then inserted the cement.The cement counter-flowed through the route and leaked out of the centrum.There is no further information is available.This report is for one (1) sistema de cemento vertecem v+.Esteril.This report is 1 of 1 for (b)(4).

• Brand Name: SISTEMA DE CEMENTO VERTECEM V+ . ESTERIL
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11970914
• MDR Text Key: 280571809
• Report Number: 8030965-2021-04751
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 017611819376250
• UDI-Public: (01)017611819376250
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.702.016S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Removal/Correction Number: N/A
• Patient Sequence Number: 1