MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM; CEMENT, BONE, VERTEBROPLASTY

Model Number 283913000

Device Problem Chemical Problem (2893)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.A manufacturing record evaluation could not be performed as the lot number could not be determined from the image provided.Photo investigation: the device was not returned.A photo-investigation was performed based on all the images.Upon inspecting all the photos provided, the cement was observed to be solidified inside the container.The root cause of the issue due to texture and viscosity of cement cannot be confirmed based on the provided photos.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo investigation.There is a possibility the cement may have solidified prematurely due to the manner with which it was stored and other environmental factors that might have an impact on the cement¿s setting time.The confidence spinal cement system kit¿s instructions for use states that the cement should be stored unopened in its original packaging, in a dry, clean place away from light, at a maximum temperature between 41° f (5° c) and 77° f (25° c).The working time at operating room and material temperature of 20 degrees celsius is 9 minutes.The handling characteristics and setting time can vary if the product has not been fully equilibrated before use.The liquid monomer should always be protected from sunlight to prevent premature polymerization.The unopened product should be stored at 68° f (20° c) for a minimum of 24 hours before use.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a posterior spinal fusion (psf) the scrub nurse noticed that the viscosity and texture of the prepared cement was grainy and thick.The cement preparation process was followed.It was mentioned that this issue has occurred approximately four additional times and was not an isolated incident.There was no surgical delay.The procedure was completed successfully.There was no known patient consequence.This report involves one (1) confidence spinal cement system confidence kit spinal cement system.This is report 1 of 1 for (b)(4).This product complaint, (b)(4), is related to (b)(4).

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE KIT SPINAL CEMENT SYSTEM
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11958231
• MDR Text Key: 266970913
• Report Number: 1526439-2021-01184
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K060300
• 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
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 73 YR