MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; DBD-LAMINECTOMY PACK

Catalog Number	DYNJ31283M
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "this pack lot is missing the pouch instr 2 pocket tape x 2.The item is not highlighted to indicate it is missing".
Additional Manufacturer Narrative
The customer reported the pack lot is missing the pouch instr 2 pocket tape x 2 and the item is not highlighted to indicate it is missing.No sample or photo was received for the investigation; finished good production records were reviewed, the correct quantities were picked for the reported work order, and the finished good pack build and bill of materials were reviewed.Based on the complaint details and investigation, the omission of the reported component, pouch instr 2 pocket tape, part number 81506, is considered to have been a manufacturing error during production assembly as both the bom and pppf require that 2 each of the component be present in the pack.Production and qc managers were notified, feedback will be provided to the build team, and the issue will be monitored for trending purposes.There were no reports of death, serious injury, medical intervention, or follow up care.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 is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: DBD-LAMINECTOMY PACK
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkat gaanuthula ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50734694
• Report Number: 1417592-2026-37066
• Device Sequence Number: 10575293
• Product Code: OJH
• UDI-Device Identifier: 40195327074594
• UDI-Public: 40195327074594
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: DYNJ31283M
• Device Lot Number: 23IMB296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown