MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. ACCESS.STABILIT; VERTEBRAL BODY CEMENT CANNULA

Catalog Number	1472/C
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that when attempting to create a percutaneous access channel into the vertebral body during a kyphoplasty procedure, the device detached when trying to remove it from the patient's spine.The procedure was successfully completed, and the foreign body remained within the patient.An additional surgical procedure may be necessary to remove the foreign body.No additional consequences to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: ACCESS.STABILIT
• Common Device Name: VERTEBRAL BODY CEMENT CANNULA
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11405819
• Report Number: 1721504-2021-00014
• Device Sequence Number: 3545210
• Product Code: MDM
• UDI-Device Identifier: 00884450390467
• UDI-Public: 884450390467
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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 Expiration Date: 11/11/2023
• Device Catalogue Number: 1472/C
• Device Lot Number: H1970798
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/16/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention