ERISMA-LP

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.

Description of Event or Problem

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.

Description of Event or Problem

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.