MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; LUMBAR LAMI PACK-LF

Catalog Number	DYNJ63463B
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, during a procedure the "cottonoid" count was "off", it was determined the component was not "radiopaque", and the "cottonoid" was unable to be found using an x-ray.The customer reported that the "missing cottonoid was eventually located and removed".The customer reported did not report any patient injury or impact related to the issue.No additional details are available related to the customer reported issue.The customer reported there was no serious injury or follow-up care required related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, during a procedure the "cottonoid" count was "off", it was determined the component was not "radiopaque", and the "cottonoid" was unable to be found using an x-ray.

• Common Device Name: LUMBAR LAMI PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23064261
• Report Number: 1423395-2025-00126
• Device Sequence Number: 10044761
• Product Code: OJH
• UDI-Device Identifier: 10193489826012
• UDI-Public: 10193489826012
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ63463B
• Device Lot Number: 25FBD371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown