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U.S. Department of Health and Human Services

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

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KALITEC MEDICAL NAVAGIO LUMBAR CAGE; INTERVERTEBRAL BODY FUSION DEVICE Back to Search Results
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.
 
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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 Key18574311
MDR Text Key333660347
Report Number3009165919-2024-00001
Device Sequence Number1
Product Code MAX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220902
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number30-TTS-2711
Device Catalogue Number30-TTS-2711
Device Lot NumberBKKR
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/24/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age81 YR
Patient SexMale
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