MAUDE Adverse Event Report: KALITEC MEDICAL NAVAGIO LUMBAR CAGE; INTERVERTEBRAL BODY FUSION DEVICE

Model Number 30-TTS-2711

Device Problem Insufficient Information (3190)

Patient Problem Neuropathy (1983)

Event Date 11/17/2023

Event Type  Injury  

Manufacturer Narrative

Initially kalitec was made aware of a potential issue with the inserter/draw rod.No report of patient injury was made.Based on the available information and evaluation of the returned instruments it was determined that no report was required.However after the distributor which returned the instrument provided additional information on (b)(6) 2024 the event was reevaluated and a report was determined to be required.The report will be made at a point greater than 30 days from when kalitec was made aware of the instrument malfunction but less than 30 days from when they were made aware of the patient injury.The time from becoming aware of the injury and the report was used to complete the expanded investigation which included the new information provided by the distributor.

Event Description

On 12/07/23 the inserter and draw rod were returned to kalitec with the indication that they failed to perform as expected during their last use.The distributor was contacted for additional details.There were no responses after two attempts.The instruments were inspected and found to be conforming to the print.Device dhrs were reviewed and no issues were identified in the manufacturing.A review of the complaint log showed no other related reports for the instruments.The third attempt to contact the distributor for additional details resulted in a phone call on 01/15/24.The distributor provided the following details: on (b)(6) 2023 a surgeon was performing a lumbar fusion procedure on an 81yo male.During placement of the navagio lumbar cage in the surgical site the implant released from the inserter.The implant was positioned using a tamp.Once positioned the surgeon noted through neuromonitoring an issue with the patient.An attempt to reattach the inserter to remove the implant was unsuccessful.The implant was removed using a different instrument and the patient was closed.The patient took a significantly longer time in recovery than anticipated.Upon waking the patient experienced neuropathy in his feet.Following the receipt of the additional details a review of the dhr for the implant used was conducted.No issues were identified in the manufacturing of the device.A review of the complaint log did not identify any previously reported issues with navagio implants.The device was not returned for the investigation.No issues were identified with the returned instrumentation and no issues were identified with the manufacturing of the implant.There is no definitive root cause identified.There is insufficient evidence to be able to identify any definitive cause of either the patient injury or for the inadvertent release of the implant from the inserter.The surgeon continues to monitor the patient.No details on planned treatment were provided.If additional information is provided this report will be supplemented.This is the first of three reports for the kalitec devices used during the procedure.This report is for the navagio implant pn 30-tts-2711 lot bkkr.

• Brand Name: NAVAGIO LUMBAR CAGE
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): KALITEC MEDICAL; 865 oviedo blvd; suite 1023; FL 32765
• Manufacturer (Section G): SIM SURGICAL; 2076 fenton logisitics park bl; st. louis MO 63026
• Manufacturer Contact: keith cannan ; 865 oviedo blvd; suite 1017; 4075452063
• MDR Report Key: 18574311
• MDR Text Key: 333660347
• Report Number: 3009165919-2024-00001
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220902
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 30-TTS-2711
• Device Catalogue Number: 30-TTS-2711
• Device Lot Number: BKKR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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: 81 YR
• Patient Sex: Male