MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG CYL VALVE WITH LRG RICKHAM RES; HAKIM CHPV

Catalog Number	NS0602
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
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 facility reported a hakim valve (id (b)(6) was implanted on (b)(6) 2021.The valve would not adjust its setting.Therefore, the valve was removed and replaced on (b)(6) 2026.The patient did not experience any signs or symptoms related to the valve¿s inability to adjust.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The hakim valve was returned for evaluation: dhr - the batch record was reviewed and there were no identified anomalies or ncs related to the finished lot.Failure analysis - the analyst was able to successfully adjust the pressure setting from approximately 30 mmh2o to 140 mmh2o, indicating that the device functioned as intended during testing.The returned device was reevaluated to assess its ability to be reprogrammed across the full specified pressure range.Initial attempts to adjust the valve setting from 140 mmh2o to 30 mmh2o were unsuccessful, including an attempt to loosen suspected residual biologics using an external magnet.Following rehydration of the valve with distilled water, the device was successfully reprogrammed to 200 mmh2o and subsequently back to 30 mmh2o, with x-ray imaging confirming the designated settings.These results demonstrated that, after rehydration, the device was capable of being reprogrammed across the full specified pressure range.Root cause - the complaint could not be confirmed in the complaint investigation and failure evaluation.A response from medical affairs notes: the inability to adjust the valve in vivo may not be able to be reproduced during the bench test following explanation and reprocessing because of a transient interference of the adjustment mechanism by biological material (e.G., proteinaceous or cellular debris) accumulated during long-term implantation, that may have been removed or displaced during cleaning and decontamination prior to evaluation.Though a root cause may not be confirmed, in-vivo transient obstruction is a plausible explanation.A potential root cause is bio-substances interfere with programming mechanism.
Event or Problem Description
N/a.

• Brand Name: PROG CYL VALVE WITH LRG RICKHAM RES
• Common Device Name: HAKIM CHPV
• 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: 24333873
• Report Number: 3014334038-2026-00009
• Device Sequence Number: 9781996
• Product Code: JXG
• UDI-Device Identifier: 10381780524663
• UDI-Public: 10381780524663
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Expiration Date: 02/28/2025
• Device Catalogue Number: NS0602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White