MAUDE Adverse Event Report: 11G IVAS ACCESS CANNULA; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Catalog Number 0306330000

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 4 events were reported for this quarter.Product return status: 1 device was not available for evaluation.3 device investigation types have not yet been determined.4 devices were labeled for single-use.4 devices were not reprocessed or reused.

Event Description

This report summarizes 4 malfunction events in which the device or cutting accessory fractured.3 events had insufficient information received.1 event which had a mild injury, illness or impairment which can be treated with minimal or no intervention.

Event Description

This report summarizes 4 malfunction events in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.2 events had insufficient information received.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: corrected data: b5, h10.4 previously reported events are included in this follow-up record.Product return status: 1 device was received.2 devices were not available for evaluation.1 device investigation type has not yet been determined.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, b6, h10 4 previously reported events are included in this follow-up record.Product return status 1 device was received.3 devices were not available for evaluation.

Event Description

This report summarizes 4 malfunction events in which the device or cutting accessory fractured.- 2 events had patient involvement; no patient impact.- 2 events had insufficient information received.

• Brand Name: 11G IVAS ACCESS CANNULA
• Type of Device: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• MDR Report Key: 10748093
• MDR Text Key: 213450778
• Report Number: 0001811755-2020-02803
• Device Sequence Number: 1
• Product Code: OAR
• UDI-Device Identifier: 37613252505991
• UDI-Public: 37613252505991
• Combination Product (y/n): N
• Number of Events Reported: 4
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0306330000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 09/30/2020; 09/30/2020
• Supplement Dates FDA Received: 01/29/2021; 10/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1