FDA Adverse Event Malfunction Summary report: N

UNKNOWN EVEREST POLYAXIAL SCREW

MDR report key: 24872014 · Received April 14, 2026

Report

Report Number
3004774118-2026-00109
Event Type
Malfunction
Date Received
April 14, 2026
Date of Event
June 30, 2025
Report Date
April 14, 2026
Manufacturer
K2M, INC.
Product Code
NKB
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
AS
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

THE ARTICLE 'HIGH FUSION RATES WITH STRUCTURED TITANIUM TLIF CAGES: A RETROSPECTIVE 1-YEAR STUDY WITH AND WITHOUT ADJACENT LEVEL DYNAMIC STABILIZATION' IN SURGERIES 2025, 6, 52 WAS REVIEWED. THE OBJECTIVE OF THE ARTICLE IS TO EVALUATE 12-MONTH FUSION OUTCOMES AND PATIENT-REPORTED OUTCOMES (PROMS) AFTER TLIF WITH STRUCTURED TITANIUM CAGES, COMPARING CASES WITH AND WITHOUT ADJACENT-LEVEL DSS. IN THIS RETROSPECTIVE COHORT STUDY, 82 PATIENTS UNDERGOING TLIF (WITH EVEREST POLYAXIAL PEDICLE SCREWS OR SCREWS FROM A DIFFERENT COMPANY) WITH ST CAGES WERE ANALYZED 41 WITH HYBRID INSTRUMENTATION (TLIF + DSS) AND 41 WITH TLIF ALONE. PROMS (ODI, VAS FOR BACK AND LEG PAIN, EQ-5D-5L) WERE ASSESSED PREOPERATIVELY AND AT 12 MONTHS. DATA WERE COLLECTED THROUGH THE NEUROPSIN INSTITUTE SPINE REGISTRY, A PROSPECTIVE OBSERVATIONAL COHORT REGISTRY THAT COLLECTS DEMOGRAPHIC, PERIOPERATIVE, AND PATIENT-REPORTED OUTCOME MEASURES (PROMS) FROM PARTICIPANTS WHO WERE >18 YEARS OF AGE AND UNDERGOING SURGICAL TREATMENT FOR SPINE-RELATED DISEASES FROM FOUR SURGEONS ACROSS THREE SITES IN (B)(6) AUSTRALIA (B)(6) HOSPITAL). FUSION WAS ASSESSED VIA CT SCANS AT 12 MONTHS. PROMS SIGNIFICANTLY IMPROVED OVER TIME IN BOTH GROUPS (P < 0.001 FOR ODI, VAS BACK, VAS LEG), BUT THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE HYBRID AND NON-HYBRID GROUPS. PATIENT-REPORTED OUTCOMES WERE ANALYZED USING MIXED TWO-WAY ANOVA TO ASSESS THE INTERACTION BETWEEN FOLLOW-UP TIMEPOINTS AND SURGICAL TECHNIQUE (TLIF WITH OR WITHOUT DSS). POST-OPERATIVELY, ONE PATIENT EXPERIENCED SCREW LOOSENING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
939377 UNKNOWN EVEREST POLYAXIAL SCREW THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB K2M, INC. UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown