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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP PEDICLE SCREW

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CLARIANCE SAS ERISMA-LP PEDICLE SCREW Back to Search Results
Model Number 18176550
Device Problem Off-Label Use (1494)
Patient Problem Failure of Implant (1924)
Event Date 07/30/2018
Event Type  Injury  
Manufacturer Narrative
The pedicle screw involved in this fixation failure, as well as the set screw loosened, have been examined to check if they have been degraded during the construct tightening. The dimensional analysis conducted demonstrates that both pedicle screw and set screw are in conformity with the specifications of the technical drawings. The visual examination does not indicate any abnormal surface issue or material issue.
 
Event Description
Two weeks post-op on a t10-l3 fusion construct for vertebral fracture treatment, the pedicle screw on contra-lateral side was pulled out of pedicle. As a consequence, the set screw loosened. The patient needed a revision surgery to resecure the construct. The construct was lengthened to l4 and pedicle screws which pulled out were replaced. The revision surgery was completed without further complications.
 
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Brand NameERISMA-LP
Type of DevicePEDICLE SCREW
Manufacturer (Section D)
CLARIANCE SAS
18 rue robespierre
beaurains, 62217
FR 62217
Manufacturer (Section G)
CLARIANCE SAS
18 rue robespierre
beaurains,
Manufacturer Contact
sylvain chambat
4809 n ravenswood ave #119
chicago, IL 60640
7738687043
MDR Report Key8149918
MDR Text Key129880323
Report Number3009962553-2018-00002
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Replace
Type of Report Initial
Report Date 12/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number18176550
Device Catalogue Number18176550
Device Lot NumberI265X
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/11/2018 Patient Sequence Number: 1
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