MAUDE Adverse Event Report: ETHICON INC. ETHICON; AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED

Catalog Number	3013SP
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information: the doctor heard about a case that a patient was paralyzed after lumbar spine surgery about two months ago.In cases where the powder is sprayed over a wide area for fusion surgery does not seem to be a problem, but the doctor thinks that the solidification also makes difficult to remove by washing if it is sprayed into narrow spaces during decompression, whether in the cervical or lumbar it will solidify and be difficult to wash away.The following information was requested, but unavailable: 1.The initial report mention "the patient had a disability in case of lumber surgery about 2 months ago after the surgery", please clarify the patient consequences?=>unk 2.Was there any associated medical or surgical intervention to treat any of the patient consequences? if so, please clarify.=>unk 3.Please provide lot number =>unk this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent a lumbar procedure on an unknown date and absorbable hemostat was used.During surgery, the patient had a disability in case of lumber surgery about 2 months ago after the surgery.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: ETHICON
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km 8.3; san lorenzo PR 00754 ; * 00754
• Manufacturer Contact: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 24781982
• Report Number: 2210968-2026-03516
• Device Sequence Number: 6064411
• Product Code: LMG
• UDI-Device Identifier: 10705031237506
• UDI-Public: 10705031237506
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N12159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: 3013SP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown