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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP MIS 6.5MM X 40MM CANNULATED POLYAXIAL SCREW

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CLARIANCE SAS ERISMA-LP MIS 6.5MM X 40MM CANNULATED POLYAXIAL SCREW Back to Search Results
Model Number 13016540
Device Problem Positioning Failure (1158)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/23/2019
Event Type  malfunction  
Manufacturer Narrative
The screw was returned to the manufacturer, however, the set screw was not returned. As a consequence, no analysis was able to be performed.
 
Event Description
The set screw would not start and engage the thread of the head of the erisma-lp mis polyaxial screw. There was a delay of 30 minutes associated with removing the screw and replacing it with an alternative pedicle screw. However, no patient harm was reported and the surgery completed without further incident.
 
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Brand NameERISMA-LP MIS
Type of Device6.5MM X 40MM CANNULATED POLYAXIAL SCREW
Manufacturer (Section D)
CLARIANCE SAS
18 rue robespierre
beaurains, 62217
FR 62217
Manufacturer (Section G)
CLARIANCE SAS
18 rue robespierre
beaurains, 62217
FR 62217
Manufacturer Contact
fadwa bahr
18 rue robespierre
beaurains, 62217
FR   62217
MDR Report Key9786270
MDR Text Key200808632
Report Number3009962553-2019-00004
Device Sequence Number1
Product Code NKB
UDI-Device Identifier03707780615032
UDI-Public(01)03707780615032
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 09/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/26/2022
Device Model Number13016540
Device Catalogue Number13016540
Device Lot NumberGA17C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/02/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/26/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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