MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD STABILIT FRACTURE KIT

Model Number	00884450379851
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges during a vertebral augmentation procedure, the tip of the augmentation system detached within the patients vertebral body and was not removed.The detached tip was cemented in place and the procedure completed without any additional consequences to the patient.
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: STABILIT FRACTURE KIT
• Common Device Name: FRACTURE KIT
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• MDR Report Key: 9945997
• Report Number: 9616662-2020-00007
• Device Sequence Number: 14191309
• Product Code: NDN
• UDI-Device Identifier: 00884450379851
• UDI-Public: 00884450379851
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 00884450379851
• Device Catalogue Number: 2003-01/C
• Device Lot Number: K1629950
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1