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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN CERTAS PLUS VALVE

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INTEGRA LIFESCIENCES SWITZERLAND SAR UNKNOWN CERTAS PLUS VALVE Back to Search Results
Catalog Number XXX-CERTAS PLUS VALVE
Device Problem Insufficient Information (3190)
Patient Problem Failure of Implant (1924)
Event Date 01/26/2021
Event Type  Injury  
Manufacturer Narrative
The certas valve (id unknown) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed. The root cause(s) of the reported issue could not be determined; however, a possible root cause for the ¿shunt failure. ¿ could be due to biological debris and protein build up interfering with the valve mechanism. If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed. Trends will be monitored for this and similar issues. At present, we consider this complaint to be closed.
 
Event Description
This is 2 of 2 reports linked to mfg report number: 3013886523-2022-00055. A physician reported a certas valve (unknown id) was implanted in a (b)(6) female via l-p shunt on (b)(6) 2019 with unknown setting. Due to shunt failure, a hakim v-p shunt (id 823842) was added on (b)(6) 2021. The v-p shunt pressure was reduced to 30 mmh2o and the patient was in the follow up. A year later, hydrocephalus was confirmed by ct and on (b)(6)2022, the hakim valve (id 823842) was removed and replaced.
 
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Brand NameUNKNOWN CERTAS PLUS VALVE
Type of DeviceCERTAS PLUS
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ
Manufacturer (Section G)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
ch-2400
le locle
SZ
Manufacturer Contact
vivian nelson
1100 campus drive
princeton, NJ 
6099362319
MDR Report Key13722207
MDR Text Key286944437
Report Number3013886523-2022-00082
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberXXX-CERTAS PLUS VALVE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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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