MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE SPINAL CMT SYS, 11C; CEMENT, BONE, VERTEBROPLASTY

Model Number 283910000

Device Problem Inaccurate Information (4051)

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

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 (b)(6) reports an event as follows: it was reported that on an unknown date that the confidence kit with expiration date (b)(6) 2021 contained devices with a different expiration date.This report is for one (1) confidence spinal cement system confidence plus kit spinal cement system 11cc.This is report 1 of 1 for (b)(4).

• Brand Name: CONFIDENCE SPINAL CMT SYS, 11C
• 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: 11893446
• MDR Text Key: 252927289
• Report Number: 1526439-2021-01049
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209623
• UDI-Public: 10705034209623
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 283910000
• Device Catalogue Number: 283910000
• Device Lot Number: 240119
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1