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	02/26/2026
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 nurse reported a hakim valve (id 823164) was implanted via ventriculoperitoneal (vp) shunt.The valve would not reprogram, therefore it was removed and replaced on (b)(6) 2026.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve (823164) was returned for evaluation.Device history record (dhr) - review of the history device records for the product code 82-3164 with lot 7563382 conformed to specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at 140 mmh2o.The valve was visually inspected; no defect was noted.The valve passed the test for programming.Occlusion, leak, reflux and pressure.The valve functions.Root cause - no root cause could be determined as the device was functional.The complaint could not be confirmed.The potential root cause for the reported issue could be due to biologicals debris, as noted in the ifu: accumulation of biological matter (i.E.Blood, protein accumulations, tissue fragments, etc.) in the programming mechanism can cause inability of the device to be reprogrammed.Clogging of the programmable valve with biological matter can cause the valve to become unresponsive to attempts to change the pressure setting.

• 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: 24647789
• Report Number: 3013886523-2026-00054
• Device Sequence Number: 9842144
• Product Code: JXG
• UDI-Device Identifier: 10381780534587
• UDI-Public: (01)10381780534587(17)300531(10)7563382
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 02/26/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2025
• 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: 62 YR
• Patient Sex: Unknown
• Patient Ethnicity: Hispanic