MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH CONFIDENCE SPINAL CMT SYS, 11C; POLYMETHYLMETHACRYLATE BONE CEMENT

Model Number 283910000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 08/05/2020

Event Type  Death  

Manufacturer Narrative

The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2020, the surgeon was doing an l1l2 vertebroplasty utilizing two (2) each confidence cement kits.We used 1 each kit at each level utilizing the entire vile of cement in each body.The case went well and we followed product instructions/technique for cement preparation.From the xray images all the cement stayed within the vertebral bodies and administered properly.After the procedure was completed and all the cement was implanted, anesthesia mentioned that the patient¿s pressure dropped down to 30.It was not alarming to me at the time and i left the room per usual to the staff lounge waiting for the next case.15 minutes later i walked back to the or and noticed through the or room window the staff administering chest compressions on the patient.I then immediately went back to the lounge to wait for the next case and stay away from the situation.While waiting in the lounge, i overheard another anesthesiologists talking about the case to another staff member.She mentioned the patient had a triple a surgery prior and was taken off blood thinners for the surgery.It was further reported that the patient died.This complaint involves two (2) devices.This report is for (1) confidence spinal cmt sys, 11c.This is report 2 of 2 (b)(4).

Event Description

It was further reported that the vertebroplasty was done to treat a vertebral body fracture.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10478316
• MDR Text Key: 205162769
• Report Number: 1526439-2020-01587
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: 10705034209623
• Combination Product (y/n): N
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 283910000
• Device Catalogue Number: 283910000
• Device Lot Number: 258835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 80 YR