MAUDE Adverse Event Report: CLARIANCE SAS ERISMA-LP; 6.5MM X 50MM POLYAXIAL SCREW

Model Number	18156550
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2025 - the polyaxial screw disassembled intraoperatively while being maneuvered, resulting in an unanticipated interruption of the surgical procedure.While the disassembly was identified by the surgeon and the component was removed and replaced, this event required additional surgical intervention.Although the procedure was completed without immediate harm to the patient, the event constitutes a malfunction of a medical device that, if it were to recur, could lead to serious injury or require surgical intervention to prevent permanent impairment or damage to a body structure.This event is reportable as a malfunction.Each screw used suring the surgerey was catalog/model # 18156550.Lot numbers were l115x (x2), and i105x (x1).Manufacture date of lot # i105x was 05/10/2019.
Event or Problem Description
The surgeon was performing revision surgery using the erisma navigated system.While inserting a screw, the tulip head detached from the screw.Another screw was used and inserted without incident.On the 2nd track of screw revisions, the tulip head became detached from two further screws.At that point, the surgeon stopped using the erisma system and completed the surgery with an alternative system.
Additional Manufacturer Narrative
07/18/2025 - the polyaxial screw disassembled intraoperatively while being maneuvered, resulting in an unanticipated interruption of the surgical procedure.While the disassembly was identified by the surgeon and the component was removed and replaced, this event required additional surgical intervention.Although the procedure was completed without immediate harm to the patient, the event constitutes a malfunction of a medical device that, if it were to recur, could lead to serious injury or require surgical intervention to prevent permanent impairment or damage to a body structure.This event is reportable as a malfunction.Each screw used suring the surgerey was catalog/model # 18156550.Lot numbers were l115x (x2), and i105x (x1).Manufacture date of lot # i105x was 05/10/2019.10/16/2025 - analysis report conclusion: the detailed context of the surgery was not available so it was not possible to determine if the surgery was performed according to the surgical technique.An excessive torque applied to the screwdriver may have contribute to screw disassembly without certainty about the context how it could have been happened.This is considered as an isolated case due to the rare occurrence (7 cases in 5 years) according to figure 1 with no impact on risk analysis.Clariance will continue to monitor this type of event as part of its pms activities and trend monitoring.
Event or Problem Description
The surgeon was performing revision surgery using the erisma navigated system.While inserting a screw, the tulip head detached from the screw.Another screw was used and inserted without incident.On the 2nd track of screw revisions, the tulip head became detached from two further screws.At that point, the surgeon stopped using the erisma system and completed the surgery with an alternative system.

• Brand Name: ERISMA-LP
• Common Device Name: 6.5MM X 50MM 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: quang tran ; 18 rue robespierre; beaurains, 62217 ; FR 62217
• MDR Report Key: 22546464
• Report Number: 3009962553-2025-00002
• Device Sequence Number: 8614889
• Product Code: NKG
• UDI-Device Identifier: 03700780617951
• UDI-Public: (01)03700780617951(10)L115X(11)210112
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K120469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 18156550
• Device Catalogue Number: 18156550
• Device Lot Number: L115X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown