MAUDE Adverse Event Report: KAHTNU SURGICAL TALKEETNA; PEDICAL SCREW, PRODUCT CODE, NKB

Model Number TPS1-55-37545

Device Problem Fracture (1260)

Patient Problem Intraoperative Pain (2662)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive at this time.The patient was unable to provide information on compliance to post operative orders or potential traumatic events such as falls.

Event Description

Patient underwent spinal fusion surgery in (b)(6) of 2020.Patient reported for 6 month follow up visit and complained of back pain.Upon examination it was identified that three of the thoracolumbar spinal screws were broken.The patient is not mentally able to provide the physician any information as to their compliance with post-operative instructions or if there had been any type of traumatic injury such as a fall.A revision surgery was performed on (b)(6) 2020 to remove the broken hardware and replace it with another manufacturer's spinal construct.

• Brand Name: TALKEETNA
• Type of Device: PEDICAL SCREW, PRODUCT CODE, NKB
• Manufacturer (Section D): KAHTNU SURGICAL; 170 e corral ave; suite 1; soldotna AK 99669
• Manufacturer Contact: craig wilcox ; 170 e. corral ave; suite 1; soldonta, AK 99669 ; 9072023111
• MDR Report Key: 11096352
• MDR Text Key: 224415602
• Report Number: 3014639843-2020-00003
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K180301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TPS1-55-37545
• Device Lot Number: 01096
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 70 YR