MAUDE Adverse Event Report: AFH0011-AVAFLEX PLUS NEEDLE 11G; INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)

Model Number 1025011000

Device Problem Fracture (1260)

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

Event Date 06/30/2021

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: 1 event was reported for this quarter.Product return status: 1 device investigation type has not yet been determined.Additional information: 1 device was labeled for single-use.1 device was not reprocessed or reused.

Event Description

This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.

Event Description

This report summarizes 1 malfunction event in which the device or cutting accessory fractured.1 event had patient involvement; no patient impact.

Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale: 1 previously reported event is included in this follow-up record.Product return status: 1 device was not available for evaluation.

• Brand Name: AFH0011-AVAFLEX PLUS NEEDLE 11G
• Type of Device: INJECTOR, VERTEBROPLASTY (DOES NOT CONTAIN CEMENT)
• MDR Report Key: 12204232
• MDR Text Key: 262708809
• Report Number: 3015967359-2021-01636
• Device Sequence Number: 1
• Product Code: OAR
• UDI-Device Identifier: 07613327374612
• UDI-Public: 07613327374612
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1025011000
• Device Catalogue Number: 1025011000
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: No
• 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