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

Catalog Number	823832
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Cerebral Edema (4403)
Date of Event	12/01/2025
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 facility reported a hakim valve (id 823832) was implanted on (b)(6) 2025.The patient noticed fluid accumulation under the scalp and returned for a follow-up.The doctor manually confirmed a fracture in the shunt valve through palpation.On (b)(6) 2025, a revision surgery was conducted to retrieve the fractured valve and replace it with a same model.The patient is in stable condition.
Additional Manufacturer Narrative
Updated fields: d4, d8, d9, g6, h1, h2, h3, h4, h6, h8, h11.The hakim valve (id 823832) was returned for evaluation.Device history record (dhr) - review of the history device records for the product code 82-3832 with lot 7330009 conformed to specifications when released to stock.Failure analysis - the position of the cam when the valve was received was at 90 mmh2o.The valve was visually inspected; the siphon guard was torn and separated from the valve.The valve passed the test for programming.The valve was flushed and failed, leaked from the housing, siphon guard was separated.The valve was examined under microscope at appropriate magnification: cut marks were observed on the siphon guard.Root cause analysis - the root cause for the leakage issue is due to human misuse.As noted in ifu: do not use sharp instruments when handling the silicone valve or catheter use shod forceps.Cuts or abrasions from sharp instruments may rupture or tear the silicone components.Do not fold or bend the valve during insertion.Incorrect insertion may cause rupture of the silicone housing.
Event or Problem Description
N/a.

• Brand Name: PROG VALVE INLINE W SG
• 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: 24011118
• Report Number: 3013886523-2025-00346
• Device Sequence Number: 21144734
• Product Code: JXG
• UDI-Device Identifier: 10381780519805
• UDI-Public: (01)10381780519805(17)281130(10)7330009
• Combination Product (Y/N): N
• PMA/510(K) Number: K221840
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 823832
• Device Lot Number: 7330009
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• 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: 12/05/2023
• 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: 33 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian