MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - MEXICALI MEDLINE; SPINAL FUSION PACK

Catalog Number	DYNJT4605
Medical Device Problem Codes	Incomplete or Missing Packaging (2312); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the bovie tip was bent from the pack; unable to use.They are being sent/packaged without tip protection.They used to be covered.This occurred when opening the pack.The tip could poke through since it is not protected.There were no reports of death, serious injury, medical intervention, or follow up care.
Event or Problem Description
Bovie tip came without plastic cover and was bent.

• Brand Name: MEDLINE
• Common Device Name: SPINAL FUSION PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - MEXICALI; calle circuito del desierto #7; parque industrial del desierto; mexicali, baja california, 21383 ; MX 21383
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25009480
• Report Number: 1423395-2026-00109
• Device Sequence Number: 13294944
• Product Code: OJH
• UDI-Device Identifier: 10198459458583
• UDI-Public: 10198459458583
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/27/2026

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: Other
• Device Catalogue Number: DYNJT4605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (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