Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTEGRA LIFESCIENCES SWITZERLAND SAR CERTAS INLIN VLV ONLY W/SPHNGD; CERTAS PLUS W/ SG Back to Search Results
Catalog Number 828804
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 11/25/2020
Event Type  Injury  
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 Description
A physician reported that on (b)(6) 2020, the (b)(6) male patient has csf retention and the certas valve was broken: the valve was implanted via l-p shunt on (b)(6) 2020 with setting 6.There were no clinical symptoms of hydrocephalus and the patient was discharged; however, on (b)(6) 2020, the patient went to the hospital because of csf retention on his back and no clinical signs of hydrocephalus were noted.It was found that the valve was broken by ct image.Therefore, on (b)(6) 2020, the valve was replaced with a new one.
 
Event Description
N/a.
 
Manufacturer Narrative
Unique device identifier (udi): (b)(4).The valve was returned for evaluation: failure analysis - the position of the cam when valve was received was at setting 6.The valve was visually inspected; the silicone housing was cut/torn around the siphon guard the complaint is confirmed.The siphon guard was visually inspected marks were noted in the siphon guard.The root cause for the issue reported by the customer was probably caused by a sharp or pointed object coming into contact with the silicone housing, as noted in the ifu silicone has a low cut / tear resistance.The root cause for the marks in the siphon guard were probably caused by a sharp or pointed object coming into contact with the siphon guard.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CERTAS INLIN VLV ONLY W/SPHNGD
Type of Device
CERTAS PLUS W/ SG
Manufacturer (Section D)
INTEGRA LIFESCIENCES SWITZERLAND SAR
rue girardet 29
rue girardet 29
le locle
SZ 
MDR Report Key11046090
MDR Text Key222650787
Report Number3013886523-2020-00262
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
K143111
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number828804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2021
Date Manufacturer Received01/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SILASCON LUMBAR CATH (MANUF BY KANEKA, PROD: 702-JJ. ; SILASCON LUMBAR CATH(MANUF BY KANEKA, PROD: 702-JJ
Patient Age67 YR
-
-