MAUDE Adverse Event Report: KALITEC DIRECT DBA KALITEC MEDICAL COSMOLOCK PEDICLE SCREW SYSTEM

Model Number 10-SSP6545

Device Problems Fracture (1260); Activation, Positioning or Separation Problem (2906)

Patient Problem Implant Pain (4561)

Event Date 08/07/2023

Event Type  malfunction  

Manufacturer Narrative

39yo male smoker that continued to smoke following original spinal fusion surgery on (b)(6) 2021 presented approximately two years post op after bending over and attempting to lift a heavy load.Two cosmolock 6.5 x 45mm screws located at s1 were identified as being broken.Patient believed he was alergic to the titanium used in the implants so revision surgery performed on (b)(6) 2023 to remove the broken screws.This is report one of two and covers one of the two broken screws.Both screws are of the same pn, size, and lot number.Screws were returned for the investigation.The screws were visually inspected.The inspection showed both screws appeared to have significant fatigue beach marks on the face of the break.One screw has approximately two thirds of the face containing beach marks, while the other screw has an even greater percentage.This shows that the screws were well fatigued prior to the ultimate breakage and most likely did not require much of a load to complete the break.The propagation of the fatigue stresses appear to be at the points on the screw shanks furthest from the construct (caudal) and in line with the rod slot.This position would be the typical location of fatigue propagation due to seeing the highest tensile stresses in a construct.Review of the device history records showed no nonconformities in the lot, that the devices were properly manufactured per the engineering requirements and material specifications using the appropriate certified materials.Trend analysis and historical data review show no other issues with any other devices from this lot of product.The user in this case did not utilize an interbody device for the fusion.This can lead to addtional stress loading on the construct over what is seen when the load is shared by an interbody device.The screws performed as intended and survived longer than the time for which they were validated to perform without issue.Most likely contributing causes to the failure were use of the system without employing an interbody device to share the load and the patient attempting to lift a heavy load.

Event Description

User reported two cosmolock pedicle screws implanted in a patient at s1 were identified as broken approximately two years post op.

• Brand Name: COSMOLOCK PEDICLE SCREW SYSTEM
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): KALITEC DIRECT DBA KALITEC MEDICAL; 865 oviedo blvd; suite 1017; oviedo FL 32765
• Manufacturer (Section G): RAM PRECISION; 11125 yankee road; centerville OH 45458
• Manufacturer Contact: keith cannan ; 865 oviedo blvd; suite 1017; oviedo, FL 32765 ; 4075452063
• MDR Report Key: 17568219
• MDR Text Key: 321381945
• Report Number: 3009165919-2023-00005
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10-SSP6545
• Device Catalogue Number: 10-SSP-6545
• Device Lot Number: BGKZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2023
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/10/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 39 YR
• Patient Sex: Male