MAUDE Adverse Event Report: MERIT MEDICAL IRELAND LTD STABILIT MX.STABILIT®.STABILIT® MX FRACTURE KIT; VERTEBROPLASTY KIT

Model Number	MX-1100L-01
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation but a lot number was provided.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that post-kyphoplasty procedure, the steerable vertebral augmentation system became stuck within the patient spine during removal.It was noted that only the tip of the vertebral augmentation device had detached within the patient's pedicle.No chance of migration or patient injury.The procedure was completed successfully.The patient tolerated the procedure well and was discharged to home as expected.No plans to remove the foreign body.
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 MX.STABILIT®.STABILIT® MX FRACTURE KIT
• Common Device Name: VERTEBROPLASTY KIT
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD; parkmore business park west; ballybrit; galway, ; EI
• MDR Report Key: 9767423
• Report Number: 9616662-2020-00002
• Device Sequence Number: 2488112
• Product Code: NDN
• UDI-Device Identifier: 00850696006615
• UDI-Public: 00850696006615
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: MX-1100L-01
• Device Catalogue Number: MX-1100L-01/B
• Device Lot Number: K1398056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 02/20/2020
• Initial Report FDA Received Date: 02/27/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention