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U.S. Department of Health and Human Services

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

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KAHTNU SURGICAL TALKEETNA PEDICAL SCREW, PRODUCT CODE, NKB Back to Search Results
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.

 
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Brand NameTALKEETNA
Type of DevicePEDICAL 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 Key11096352
MDR Text Key224415602
Report Number3014639843-2020-00003
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
PMA/PMN NumberK180301
Number of Events Reported1
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 Received12/30/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberTPS1-55-37545
Device LOT Number01096
Was Device Available For Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
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 TREATMENT DATA
Date Received: 12/30/2020 Patient Sequence Number: 1
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