MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; LAMINECTOMY MERCY FT SMITH

Catalog Number	DYNJ89525
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
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
According to the customer, there was a tear in the outer packaging when being unboxed and stored, which did not occur during use, on an unspecified date, and did not involve a patient, injury, or death.There was no follow-up care, medical and/or surgical intervention or treatment required.
Event or Problem Description
Hole in pouch.

• Brand Name: MEDLINE
• Common Device Name: LAMINECTOMY MERCY FT SMITH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24799800
• Report Number: 1423395-2026-00073
• Device Sequence Number: 9548708
• Product Code: LRO
• UDI-Device Identifier: 10198459276675
• UDI-Public: 10198459276675
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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
• Device Catalogue Number: DYNJ89525
• Device Lot Number: 25FBM027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2025
• 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