MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; LAMINECTOMY

Catalog Number	DYNJ910335
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on 9/9, "the neuro sponges that come in the custom pack, laminectomy were not showing upon on the x-ray".
Additional Manufacturer Narrative
According to the facility on 9/9, "the neuro sponges that come in the custom pack, laminectomy were not showing upon on the x-ray".The facility confirmed that the patient had to be reopened up via surgery to removed the patties.The facility stated that the patient is fine.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: LAMINECTOMY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20398627
• Report Number: 1423395-2024-00488
• Device Sequence Number: 3579127
• Product Code: OJH
• UDI-Device Identifier: 40195327630967
• UDI-Public: 40195327630967
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/08/2024

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: DYNJ910335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown