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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRAL LUMBAR DRAINING SET; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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INTEGRA LIFESCIENCES PRODUCTION CORPORATION INTEGRAL LUMBAR DRAINING SET; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 910420
Device Problems Break (1069); Entrapment of Device (1212); Appropriate Term/Code Not Available (3191)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/30/2020
Event Type  malfunction  
Event Description
On 9/30, the patient has a left carotid subclavian bypass in preparation for tevar.On 10/1, the patient has tevar.Anesthesia placed lumbar spinal fluid drain in preparation for tevar.On 10/2, surgeon notes that a piece of spinal drain broke off during removal.Ct done - catheter noted.Consult to spinal surgery.On 10/3, the patient goes to operating room for removal of catheter, laminectomy and duratory repair.Post-op repeat ct scan done.Repeat ct scan shows 1/2 of catheter remains in spine.Fda safety report id #: (b)(4).
 
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Brand Name
INTEGRAL LUMBAR DRAINING SET
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
MDR Report Key11154379
MDR Text Key226651986
Report NumberMW5098763
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/31/2021
Device Model Number910420
Device Catalogue Number910420
Device Lot Number0210121
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age64 YR
Patient Weight88
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