MAUDE Adverse Event Report: K2M, INC. SET SCREW; ATR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	101-10001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status of the device/devices is currently unknown.
Event or Problem Description
A physician reported four denali set screws backed-out post-operatively leading to revision surgery.This record captures the fourth of the four set screws.
Event or Problem Description
A physician reported four denali set screws backed-out post-operatively leading to revision surgery.This record captures the fourth of the four set screws.
Additional Manufacturer Narrative
Correction to d.3.And g.1.: updated from 'stryker spine- leesburg' to 'k2m, inc.' upon review of provided x-rays, it was observed that bilateral screws at the caudal end of the construct disengaged from their associated rods.There was no issue found with the fourth denali set screw.Therefore, this device is concomitant.

• Brand Name: SET SCREW; ATR
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9120800
• Report Number: 3004774118-2019-00101
• Device Sequence Number: 3643414
• Product Code: NKB
• UDI-Device Identifier: 10888857003842
• UDI-Public: 10888857003842
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• 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,Followup
• Report Date (Section B): 03/17/2020

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
• Operator of Device: Health Professional
• Device Model Number: 101-10001
• Device Catalogue Number: 101-10001
• Device Lot Number: JEWU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/27/2019
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 03/17/2020
• 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