MAUDE Adverse Event Report: TEKNIMED SAS INVICTUS; INVICTUS BONE CEMENT

Catalog Number	17095-S-1
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	04/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4) units of the bone cement lot 045a23071 have been sold individually between 02-mar-2023 and 18-apr-2023, this is the first claim received.Physico-chemical characteristics, functional characteristics and microbiological controls of the batch 045a23071 are compliant.
Event or Problem Description
The invictus spinal cement system 17095-s lot 060423095 is an assembly of 2 devices: - purekit t060425 lot 060423014 - invictus bone cement 17095-1-s lot 045a23071 surgeon intended to use invictus fenestrated system with invictus spinal cement system (17095-s) to augment fenestrated screws in lumbar spine to improve fixation strength in osteoporotic bone.Using visual information and a stopwatch, the speed of injection was faster than what is recommended per the ifu.Observations show an injection speed of approximately 1 revolution per 2 seconds, compared to the recommended 1 revolution per 4 seconds.Verbal instructions on injection speed were given to the surgeon from the sales representative and a development engineer prior to the start of cement injection, which was not followed.Approximately 10 minutes after injection of cement the patient experienced an embolism.After prompt response from the surgical team, the patient stabilized.

• Brand Name: INVICTUS
• Common Device Name: INVICTUS BONE CEMENT
• Manufacturer (Section D): TEKNIMED SAS; 8 rue du corps franc pommies; vic-en-bigorre, 65500 ; FR 65500
• Manufacturer (Section G): TEKNIMED SAS; 8 rue du corps franc pommies; vic-en-bigorre france, 65500 ; FR 65500
• Manufacturer Contact: clementine demont ; 8 rue du corps franc pommies; vic-en-bigorre france, 65500 ; FR 65500
• MDR Report Key: 18052152
• Report Number: 9615788-2023-00002
• Device Sequence Number: 5954722
• Product Code: NDN
• UDI-Device Identifier: 03701505800559
• UDI-Public: 03701505800559
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K221926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 17095-S-1
• Device Lot Number: 045A23071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PUREKIT T060425
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown