MAUDE Adverse Event Report: KALITEC MEDICAL COSMOLOCK; PEDICLE SCREW

Model Number 10-SSP-7545

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2023

Event Type  malfunction  

Event Description

Surgeon identified a broken pedicle screw at s1 during a post op exam 5 months following surgery.

Manufacturer Narrative

On (b)(6) 2023 the user reported to the distributor that he had a patient that had undergone a three level (l4 - s1) spinal fusion procedure present at an exam five months post operative with a broken pedicle screw at s1.The distributor contacted kaltiec.The user provided an x-ray which confirms the broken screw.The patient is asymptotic and at the present time the surgeon does not intend to conduct a revision surgery but will continue to monitor the patient.The surgeon did not utilize interbody devices for the surgery instead packing the space between the vertebrae with bone graft material.This substantially increases the load on the supplemental fixation system.The patient was described as "active" but it is not clear if the user provided post operative direction to restrict activities as is described in the instructions for use, if the user did delivery these instructions and the patient failed to comply, or if the patient's activity level was within the expected level of physical activity.A review of the product dhr shows the device was properly manufactured from the required materials and was found to be conforming to all specifications upon receipt from the manufacturer.Because the broken screw remains implanted a complete investigation cannot be completed and as such no true root cause of the failure can be established.If the user decides to perform a revision surgery at some time in the future and the device becomes available for evaluation a supplemental report will be filed.

• Brand Name: COSMOLOCK
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): KALITEC MEDICAL; 865 oviedo blvd; suite 1017; oviedo FL 32765
• Manufacturer (Section G): RAM PRECISION; 11125 yankee rd; centerville OH 45458
• Manufacturer Contact: keith cannan ; 865 oviedo blvd; suite 1017; oviedo, FL 32765 ; 4075452063
• MDR Report Key: 17369975
• MDR Text Key: 319520434
• Report Number: 3009165919-2023-00004
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-SSP-7545
• Device Catalogue Number: 10-SSP-7545
• Device Lot Number: BHFF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• 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 Age: 65 YR
• Patient Sex: Female