MAUDE Adverse Event Report: AXIS360 SURGICAL INC TALKEETNA; PEDICAL SCREW

Model Number TPS1-55-37545

Device Problem Mechanical Problem (1384)

Patient Problem Discomfort (2330)

Event Date 08/01/2019

Event Type  Injury  

Manufacturer Narrative

The results of the investigation at this time are inconclusive as device has not been explanted.Based upon the information available and the evaluation of the x-ray images, the event appears to be due to device fatigue which could be attributed to repeated stresses on the bone screw/rod interface prior to bone fusion.It is unknown if the patient followed surgeon's post operative instructions for partial weight-bearing or use of immobilization devices.The instructions for use shares information on the increased risk of breakage of a temporary internal fixation device during postoperative rehabilitation if the patient is active.

Event Description

Patient presented with a complaint of back pain.Plain film x-rays revealed a broken screw at the s1 level.Revision surgery planned to remove broken hardware and replace.

• Brand Name: TALKEETNA
• Type of Device: PEDICAL SCREW
• Manufacturer (Section D): AXIS360 SURGICAL INC; 170 e corral ave suite 1; soldotna AK 99669
• Manufacturer Contact: craig wilcox ; 170 e. corral ave suite 1; soldotna, AK 99669 ; 9072023111
• MDR Report Key: 8947850
• MDR Text Key: 156100911
• Report Number: 3014639843-2019-00001
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: B644TPS155375450
• UDI-Public: +B644TPS155375450/$$700412/16D20181203/Q1T
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TPS1-55-37545
• Device Catalogue Number: TPS1-55-37545
• Device Lot Number: 00412
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2018
• 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: 59 YR
• Patient Weight: 108