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

Catalog Number 2003/A

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 05/23/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account reported that during bone preparation with the osteotome and while trying to pull back the instrument the flexible tip of the instrument broke inside the vertebral body.An additional procedure was performed to remove the piece.The procedure was finished with cement augmentation delivered monopedicular.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed.The root cause was determined to be use of the device where contraindicated.A review of the complaint database was performed and no similar complaints for this lot number were found.A review of the device history record was performed and no exception documents were found.

• Brand Name: STABILIT VERTEBROPLASTY KIT
• Type of Device: VERTEBROPLASTY KIT
• Manufacturer (Section D): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer (Section G): MERIT MEDICAL IRELAND LTD.; parkmore industrial estate; galway, ; EI
• Manufacturer Contact: casey hughes, ms, cqe, csqp ; 1600 west merit parkway; south jordan, UT 84095
• MDR Report Key: 6646421
• MDR Text Key: 77727050
• Report Number: 9616662-2017-00020
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 2003/A
• Device Lot Number: K1091575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/16/2017
• Supplement Dates Manufacturer Received: Not provided; 09/11/2017
• Supplement Dates FDA Received: 06/22/2017; 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR