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

Model Number 283913000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2022

Event Type  Injury  

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.Date of event: only the event month and year are known.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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 synthes reports an event in switzerland as follows: it was reported that during a procedure on an unknown date in (b)(6) 2022, a cement leak occurred in the left side canal during an l1 kyphoplasty.The material used was the 4.7mm access kit.The surgery was delayed by 90 minutes due to the event.The surgeon performed a laminectomy, decompression, and partial cement removal in response to the event.The procedure was completed successfully, but bits and pieces of the cement remained in the canal.The patient was reported to be doing fine post-operatively.No further information is available.This report involves one confidence spinal cement system confidence kit spinal cement system.(b)(4) report the same event.This is report 1 of 1 for (b)(4).

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.

Event Description

It was reported on december 7, 2022.

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.H3, h4, h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the provided series of radiographs revealed that there was found cement leak.The allegation of leak - during use was confirmed.The root cause for this failure mode is not established.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for confidence kit, no needles.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a manufacturing record evaluation was performed for the finished device product code: 283913000, lot number: 346722.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 21/07/2022.Qty: (b)(4).Cement number: product code : 183901001 / batch number : 3766120.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.D10: date of concomitant therapy was on (b)(6) 2022.

• 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: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 16085488
• MDR Text Key: 306500928
• Report Number: 1526439-2023-00003
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K060300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283913000
• Device Catalogue Number: 283913000
• Device Lot Number: 346722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ACCESS KIT 4.7.; INFLATION SYSTEM, STERILE.; INFLATION SYSTEM, STERILE.; SYNFLATE VERTEBRAL BALLOON LRG.
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female