MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD PROG VALVE INLINE W SG 823162; INTERNAL CSF DRAINAGE

Catalog Number	823162
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Headache (1880)
Date of Event	01/16/2026
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 823162) was implanted approximately in 2019.The patient presently had alternating headache and non-headache days.The valve showed an approximate setting of 130.Medical staff tried to reset, but it would not take.X-rays showed that the mechanism in the device had separated and came into two pieces, so it was not working at all.Therefore, the valve was removed and replaced on (b)(6) 2026.All parts have been recovered.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The hakim valve (id 823162) was returned for evaluation: device history record (dhr) - no discrepancies were noted for the product being accepted.Failure analysis - the valve was visually inspected; the stator and the cam were dislodged.The program, flush and leak test could not be performed as the cam was dislodged.The pressure test could not be performed as the valve was not programable.The valve was dismantled and was examined under microscope at appropriate magnification, marks and a bump from the pivot was noted on the casing.Root cause analysis - the root cause for issue reported by the customer is due to the dislodged stator.The root cause for the dislodged stator noted during the investigation is due to the valve receiving a hard knock.The root cause for the bump marks in the valve casing noted during the investigation and the damaged cam mechanism is due to the valve receiving a hard knock.

• Brand Name: PROG VALVE INLINE W SG 823162
• 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: 24278686
• Report Number: 3013886523-2026-00014
• Device Sequence Number: 8318919
• Product Code: JXG
• UDI-Device Identifier: 10381780519232
• UDI-Public: 10381780519232
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• 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: 823162
• Device Lot Number: 1280601
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 02/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 65 YR
• Patient Sex: Female
• Patient Race: White