MAUDE Adverse Event Report: Depuy Spine Inc EXPEDIUM; FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	179702000
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2026
Type of Reportable Event	Serious Injury

• Brand Name: EXPEDIUM
• Common Device Name: FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 50808477
• Report Number: 1526439-2026-01461
• Device Sequence Number: 8644381
• Product Code: KWQ
• UDI-Device Identifier: 10705034064307
• UDI-Public: (01)10705034064307(10)438473
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142460
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 179702000
• Device Lot Number: 438473
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/21/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Supplement Date Received by Manufacturer: 09/21/2026; 09/23/2026; 09/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/22/2026; 09/24/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown