MAUDE Adverse Event Report: KALITEC MEDICAL COSMOLOCK; PEDICLE SCREW

Model Number 10-SSP-7545

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

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

User report to distributor.73 yo female underwent a two level l4-s1 spinal fusion procedure on (b)(6) 2022.Broken pedicle screw at s1 identified during four month post operative exam.Patient currently asymptotic.User plans to leave the screw implanted and monitor at this time.No device returned for the investigation.Patient reported falling on her back approximately one week prior to the exam.Some pain at the time of the fall.Radiographs show break of the screw shank approximately 10mm below the screw tulip.Most likely root cause of the breakage is the patient's fall.

Event Description

User reported identifying a broken pedicle screw at s1 in a two level spinal fusion supplemental fixation construct during a patient's four month post-op exam.

• 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: 16676252
• MDR Text Key: 313195983
• Report Number: 3009165919-2023-00002
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• 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: 03/24/2023
• 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 Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female