MAUDE Adverse Event Report: Depuy Spine Inc CONFIDENCE SPINAL CEMENT SYSTEM; CEMENT, BONE, VERTEBROPLASTY

Catalog Number	283913000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction

• Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM
• Common Device Name: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): Depuy Spine Inc; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; +1(908)386-3534
• MDR Report Key: 50841885
• Report Number: 1526439-2026-01465
• Device Sequence Number: 10263312
• Product Code: NDN
• UDI-Device Identifier: 10705034209630
• UDI-Public: (01)10705034209630
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 283913000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/31/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 09/21/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown