MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NEURO PACK

Catalog Number	DYNJ80768B
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2024, "the surgeon was irrigating with the asepto and the syringe part of the asepto shot off and hit the patients exposed spinal cord.".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2024, "the surgeon was irrigating with the asepto and the syringe part of the asepto shot off and hit the patients exposed spinal cord.The patient had a decrement of sensory signals on the sensory motor test and did improve to 75% of baseline.The patient was stable after surgery".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: NEURO PACK
• 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: 20451961
• Report Number: 1423395-2024-00491
• Device Sequence Number: 7082239
• Product Code: OJG
• UDI-Device Identifier: 40195327394289
• UDI-Public: 40195327394289
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/15/2024

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: DYNJ80768B
• Device Lot Number: 24GBE317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 83 YR
• Patient Sex: Male
• Patient Weight: 70 KG