SCARLET AC-TI

Additional Manufacturer Narrative

AFTER COMPLAINT RECEPTION, THE MANUFACTURING FOLDER OF THE CAGES (BATCH A-9853 AND BATCH 8-3679), AND THE SCREW (BATCH 8-3183) HAVE BEEN REVIEWED. THE ANALYSIS ON THE MANUFACTURING DOCUMENTS AND CONTROL QUALITY DOCUMENTS CONFIRMED THAT RAW MATERIALS AND PRODUCTION PROCESSES WERE CONFORMING TO THE SPECIFICATIONS. THERE WERE NO NON-CONFORMITIES OBSERVED DURING THE MANUFACTURING PROCESS OF BOTH BATCHES.FOR THE CAGE BATCH A-9853: THERE WERE IN TOTAL (b)(4) UNITS PRODUCED ON 2ND JULY 2025, OF WHICH 21 UNITS HAVE BEEN ALREADY IMPLANTED. THIS IS THE FIRST COMPLAINT WE RECEIVED ABOUT THIS BATCH. FOR THE CAGE BATCH 8-3679: THERE WERE IN TOTAL (b)(4) UNITS PRODUCED ON 25TH OCTOBER 2024, OF WHICH 18 UNITS HAVE BEEN ALREADY IMPLANTED. THIS IS THE FIRST COMPLAINT WE RECEIVED FROM THIS BATCH. FOR THE SCREW BATCH 8-3183: THERE WERE IN TOTAL (b)(4) UNITS PRODUCED ON 13TH AUGUST 2024, OF WHICH 150 UNITS HAVE BEEN ALREADY IMPLANTED. THIS IS THE FIRST COMPLAINT WE RECEIVED FROM THIS BATCH.THE COMPLAINT HISTORY REVIEW FOR ALL BATCHES INVOLVED, DID NOT IDENTIFY ANY LOT-SPECIFIC QUALITY CONCERNS.

Description of Event or Problem

WE RECEIVED A COMPLAINT ON (b)(6) 2026 FROM THE US (REFERENCE NUMBER CPT(b)(4)) REPORTING A SCREW BACKOUT DURING A POST-OPERATION VISIT.THE CUSTOMER COMPLAINT FORM REPORTS: "DEVICE FAILURE. DURING POST-OP VISIT, X-RAYS SHOWS DEVICE IS BACKING UP. ORIGINAL DATE OF SURGERY WAS (b)(6) 2025".THE INVOLVED DEVICE IN THIS COMPLAINT IS A SECURED LORDOTIC ANTERIOR CERVICAL CAGE, COMPOSED OF 1 CAGE AND 2 SCREWS. 2 SECURED LORDOTIC ANTERIOR CERVICAL CAGES HAS BEEN IMPLANTED (C4-C5 AND C6-C7), BUT ONLY 1 (C6-C7) SHOWS A SCREW BACK-UP.THERE IS NO IMPACT ON THE PATIENT'S HEALTH REPORTED SINCE THEN.