MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE 823164; INTERNAL CSF DRAINAGE

Catalog Number	823164
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A physician reported a hakim valve (id 823162) was implanted due to congenital hydrocephalus via ventriculoperitoneal (vp) shunt on (b)(6) 2024 with unknown setting.The pressure setting could not be changed; therefore, the device was explanted and replaced on (b)(6) 2025.Primary disease: congenital hydrocephalus.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d1, d2a, d4, d9, g3, g6, h2, h3, h4, h11 the hakim valve (id 823164) was returned for evaluation.Device history review: the product code 82-3164 with lot 6331809, conformed to the specifications when released to stock.Failure analysis: the position of the cam when the valve was received was at setting 120 mmh2o.The valve was visually inspected; siphon guard broken and separated.The valve passed the test for programming and pressure.The valve was not flushed as the siphon guard was broken.The valve was leak tested and failed.The valve was not reflux tested as the siphon guard was broken.The valve was examined under microscope at appropriate magnification: cuts marks observed on the siphon guard.Root cause analysis: the possible root cause for the issue reported by the customer, is probably due to biological debris and protein build up interfering with the valve.The root cause for the leak test failed is due to the tear in the housing.The root cause for the ¿tear mark¿ could be due a sharp or pointed object coming into contact with the valve in view of the tear mark on the needle chamber.As noted in the surgical procedure precautions section in ifu, silicone has a low cut/tear resistance.

• Brand Name: PROG VALVE INLINE 823164
• Common Device Name: INTERNAL CSF DRAINAGE
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 24011067
• Report Number: 3013886523-2025-00347
• Device Sequence Number: 11983875
• Product Code: JXG
• UDI-Device Identifier: 10381780519249
• UDI-Public: (01)10381780519249(17)270331(10)6331809
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 823164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 MO
• Patient Sex: Male