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

Model Number	TPS1-55-37545
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation at this time are inconclusive.Based upon the information available 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.The patient was non-compliant to doctor's post-operative orders.Back brace was not worn as instructed.It was reported that the patient was quite active immediately following surgery performing heavy lifting and manual labor 3 weeks post op.The doctor reported that the patient developed a pseudarthrosis and non-union which could be attributed to lack of compliance with post-operative orders.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 or Problem Description
Patient presented with a complaint of back pain.Plain film x-rays and a ct scan revealed a failed fusion.A revision surgery was scheduled and completed on (b)(6) 2019.During the revision surgery it was discovered that one of the screws had broken.

• Brand Name: TALKEETNA
• Common Device Name: PEDICAL SCREW
• Manufacturer (Section D): AXIS360 SURGICAL INC; 170 e corral ave suite 1; soldotna AK 99669
• MDR Report Key: 9221431
• Report Number: 3014639843-2019-00002
• Device Sequence Number: 14133741
• Product Code: NKB
• UDI-Device Identifier: B644TPS155375450
• UDI-Public: +B644TPS155375450/$$700412/16D20181203/Q1T
• Combination Product (Y/N): N
• PMA/510(K) Number: K180301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2019

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR