MAUDE Adverse Event Report: KALITEC MEDICAL COSMOLOCK; PEDICLE SCREW

Model Number 11-LCL-0000

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 11/14/2022

Event Type  malfunction  

Event Description

Disassociation of a locking cap from a screw discovered on post operative x-rays.

Manufacturer Narrative

Reported to kalitec on (b)(6) 2022 by a distributor that during a 30 day post operative review conducted by a surgeon, patient x-rays revealed that the locking cap had dissociated from the pedicle screw tulip at l3 on a pedicle screw construct which runs from t10 to l3.No patient symptoms.Surgeon intends to leave product in place.No lot data provided for the screw or locking cap.Without the device it is impossible to identify a root cause of the failure.

• 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 road; centerville OH 45458
• Manufacturer Contact: keith cannan ; 865 oviedo blvd; suite 1017; oviedo, FL 32765 ; 4075452063
• MDR Report Key: 15970745
• MDR Text Key: 306205332
• Report Number: 3009165919-2022-00001
• 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): Y
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 11-LCL-0000
• Device Catalogue Number: 11-LCL-0000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 30 YR
• Patient Sex: Male