MAUDE Adverse Event Report: Stryker Instruments-a division of Stryker Corp AVAFLEX CURVED NEEDLE W/ CANNULA; Injector, Vertebroplasty (Does Not Contain Cement)

Catalog Number	1025011000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between january 1 ¿ march 31 2026.This report summarizes 1 event for the failure: fracture.- 1 event had no health consequences or impact.
Additional 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.Evaluation findings (results/components) 1 device: results pending completion of investigation / needle product disposition 1 device: product disposition is not yet determined additional information 1 device was labeled for single-use.1 device was not reprocessed or reused.

• Brand Name: AVAFLEX CURVED NEEDLE W/ CANNULA
• Common Device Name: Injector, Vertebroplasty (Does Not Contain Cement)
• Manufacturer (Section D): Stryker Instruments-a division of Stryker Corp; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): Stryker Instruments-Kalamazoo; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; +1(269)323-7700
• MDR Report Key: 24954297
• Report Number: 3015967359-2026-99266
• Device Sequence Number: 5278142
• Product Code: OAR
• UDI-Device Identifier: 07613327374612
• UDI-Public: 07613327374612
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2026

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 Catalogue Number: 1025011000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown