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

Catalog Number MX-2100L-01/B

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 03/12/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The physician alleges that during a vertebral [l5] augmentation, the distal end of the osteotome detached within the patient.The physician states that patient's lower lumbar was extremely sclerotic because of a previous fracture thus making it extremely difficult to create the necessary pathways for cement delivery.When advancing the device into the patient's spine, the tip of the osteotome became stuck within the lumbar region.The physician made several attempts to remove the device.Removal was unsuccessful.The detached tip was then cemented in place with high viscosity cement.The patient was discharged without delay.

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
• Type of Device: FRACTURE KIT
• Manufacturer (Section D): MERIT MEDICAL IRELAND, LTD.; parkmore industrial estate; ballybrit; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND, LTD.; parkmore industrial estate; ballybrit; galway, ; EI
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 merit parkway; south jordan 84095
• MDR Report Key: 7362734
• MDR Text Key: 103406576
• Report Number: 9616662-2018-00007
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

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 Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: MX-2100L-01/B
• Device Lot Number: K1183367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 05/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1