MAUDE Adverse Event Report: DEPUY SPINE INC CONFIDENCE HALF DOSE KIT (5CC); CEMENT, BONE, VERTEBROPLASTY

Model Number 283905000

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported intra-operatively, during the insertion of the cement, the cement seemed to protrude anteriorly.After the introduction of the cement an ap and lat fluoro-imaging was taken to confirm that the cement had stayed with the borders of the vertebral body.This report is for a confidence cement.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) reports an event as follows: it was reported intra-operatively, during the insertion of the cement, the cement seemed to protrude anteriorly.After the introduction of the cement an ap and lat fluoro-imaging was taken to confirm that the cement had stayed with the borders of the vertebral body.This report is for a confidence cement.This is report 1 of 1 for (b)(4).

• Brand Name: CONFIDENCE HALF DOSE KIT (5CC)
• 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: 13542102
• MDR Text Key: 285693923
• Report Number: 1526439-2022-00222
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 10705034209555
• UDI-Public: (01)10705034209555
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 283905000
• Device Catalogue Number: 283905000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• 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
• Treatment: UNK - SCREW: VERSE FENESTRATED.; UNKNOWN INSERTION INSTRUMENTS.