MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND STABILIT® FIRST FRACTURE KIT.; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	2003-01
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges during the procedure when removing the working cannula.The cannula broke off inside of the bone in the pedicel.A follow procedure will be needed with a spine surgeon to remove the broken piece.No additional patient consequences to report.

• Brand Name: STABILIT® FIRST FRACTURE KIT.
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer (Section G): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit,; galway ; EI
• Manufacturer Contact: bryson heaton rn ; 1600 merit parkway; south jordan, UT 84084 ; 8012531600
• MDR Report Key: 20578360
• Report Number: 9616662-2024-00040
• Device Sequence Number: 12804628
• Product Code: NDN
• UDI-Device Identifier: 00884450315903
• UDI-Public: 884450315903
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K072496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 2003-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown