MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; LAMINECTOMY PACK

Catalog Number	DYNJ84929D
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that "a raytec sponge was packed into a spine surgical wound with multiple other raytec sponges, as is standard practice in these procedures.When removed, one of the radiopaque strips from the raytec sponge was left behind in the surgical wound.The radiopaque strip was removed from the wound and the procedure continued.The remaining raytec sponges from the pack were examined and it was noted the radiopaque strips were loose in many of them.The remaining raytec sponges were passed off the surgical field and new ones, from a different vendor, were opened and used to complete the procedure." it has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
Radiopaque strips from the raytec sponge was left behind in the surgical wound.
Additional Manufacturer Narrative
Updated h6.

• Brand Name: MEDLINE
• Common Device Name: LAMINECTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24714173
• Report Number: 1423395-2026-00055
• Device Sequence Number: 20336727
• Product Code: OJH
• UDI-Device Identifier: 10198459370267
• UDI-Public: 10198459370267
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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
• Device Catalogue Number: DYNJ84929D
• Device Lot Number: 25JMD200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/09/2025
• 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