MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÀRL CONFIDENCE SPINAL CEMENT SYSTEM; CEMENT, BONE, VERTEBROPLASTY

Model Number 283913000

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Event Description

After cement was mixed in unit, prior to installing through needle in vertebrae, the delivery device appeared to be cracked and the cement was leaking around the housing.Kit aborted and new vertebroplasty kit opened to complete procedure.Procedure completed without incident or harm to patient or operator.Manufacturer response for vertebroplasty kit, depuy confidence kit spinal cement system (per site reporter).No response yet.

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÀRL; depuy, inc.; 325 paramount dr.; raynham MA 02767
• MDR Report Key: 8248092
• MDR Text Key: 133074366
• Report Number: 8248092
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Device Lot Number: 205379
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA