MAUDE Adverse Event Report: Depuy Spine Inc EXPEDIUM; EXTRACTOR

Catalog Number	279702080
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction

• Brand Name: EXPEDIUM
• Common Device Name: EXTRACTOR
• 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: 50742686
• Report Number: 1526439-2026-01433
• Device Sequence Number: 18683584
• Product Code: HWB
• UDI-Device Identifier: 10705034198477
• UDI-Public: (01)10705034198477(10)BV880548
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• 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: 279702080
• Device Lot Number: BV880548
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/20/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Supplement Report FDA Received Date: 09/15/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown