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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCICENCS IMPLANTS SA INTEGRAL LUMBAR DRAINAGE SET (ILDS) EXTERNAL DRAINAGE SYSTEMS

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INTEGRA NEUROSCICENCS IMPLANTS SA INTEGRAL LUMBAR DRAINAGE SET (ILDS) EXTERNAL DRAINAGE SYSTEMS Back to Search Results
Catalog Number 910420
Device Problems Obstruction of Flow (2423); Migration (4003)
Patient Problem Erosion (1750)
Event Date 01/23/2021
Event Type  Injury  
Manufacturer Narrative
The device involved in the reported incident was discarded as per customer. However, an investigation has been initiated based on the reported information. Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
This is 1of 2 reports for the 1st drain placed, which is linked to mfg report number 9612007-2021-00011: a facility reported that two external lumbar drains (product id 910420) were placed in the patient and both encountered the same problem. The first drain no longer drained the next day, so they reinserted a new drain. There were no problems perioperatively, until several days after the second drain was placed, when it was observed that there was "lack of permeability of the drain and leakage around the skin opening of the drain". The surgeon had to make a laminectomy to the patient between l4 and l5 to take back the parts of the drains which migrated in the extra dural part. The drains had been put between the l5 and s1. The catheters were both cut. The patient is a male (more than 70 years old) with a lot of arthrosis. The surgeon think that the catheters have been cut because there was little place to introduce them due to the arthrosis of the patient, and as the patient was not immobile in orl service, the arthrosis might have cut the catheters because of the movement of the patient. No additional information has been provided.
 
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Brand NameINTEGRAL LUMBAR DRAINAGE SET (ILDS)
Type of DeviceEXTERNAL DRAINAGE SYSTEMS
Manufacturer (Section D)
INTEGRA NEUROSCICENCS IMPLANTS SA
2905 route des dolines
2905 route des dolines
sophia antipolis F-069 21
FR F-06921
Manufacturer (Section G)
INTEGRA NEUROSCICENCS IMPLANTS SA
2905 route des dolines
sophia antipolis F-069 21
FR F-06921
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 08536
6099362319
MDR Report Key11376570
MDR Text Key240414870
Report Number9612007-2021-00010
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K924600
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number910420
Device Lot Number0218268
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/04/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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