PERLA TL

Description of Event or Problem

WE RECEIVED A COMPLAINT FROM FRANCE (B)(6) ON (B)(6) 2026: INFECTION OF SURGICAL SITE AND ROD MOBILITY. THE CASE RELATED TO THE INFECTION WAS REGISTERED UNDER CPT-4636 (NOT REPORTABLE) AND THE CASE RELATED TO THE ROD MOBILITY WAS REGISTERED UNDER CPT-4637 (REPORTABLE). DESCRIPTION OF THE INCIDENT: INITIAL SURGERY WITH DEVICE IMPLANTATION ON (B)(6) 2026. A SURGICAL REVISION WAS REALIZED ON (B)(6) 2026 DUE TO SURGICAL SITE INFECTION WITH DEBRIDEMENT. DURING THIS NEW SURGERY, THE SURGEON NOTED ROD MOBILITY IN A HOOK DESPITE PROPER TIGHTENING. THE SETSCREW WAS REPLACED AND THE ROD IS NOW STABLE. NO CLINICAL SYMPTOMS, NO HEALTH EFFECTS DUE TO THIS ROD MOBILITY. WE DECIDED TO REPORT THE CASE TO THE FDA AS THE PRODUCT IS MARKETED IN THE US.

Additional Manufacturer Narrative

SETSCREW RECEIVED ON (B)(6) 2026; INVESTIGATION ONGOING.