MAUDE Adverse Event Report: K2M, INC. FOUNDATION SCREW; SIZE 6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06545D
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/26/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a mesa foundation screw tulip disengaged post-operatively.
Event or Problem Description
Event occurred on patient left side.
Additional Manufacturer Narrative
Device has been received, pending investigation.
Event or Problem Description
It was reported that the tulip of a mesa foundation screw on the left side disengaged post-operatively.Revision surgery has occurred.
Additional Manufacturer Narrative
Visual inspection: the device was inspected.The signs of use were evident on the implant.Markings consistent with screw insertion, screw locking, and removal were visible on all the screws.The screw was fully locked, as reported.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: to final lock the mesa screws, grasp the center shaft and gently apply a downward force to engage the distal end of the quick locker onto the screw head.Ensure the shaft of the instrument is co-linear with the implant.A gentle axial tug should then be performed to confirm docking.Squeeze the handle to fully lock the mesa screw.To disengage the instrument, fully open the handle and remove the quick locker from the surgical site.Note: ensure at least 5 mm of rod overhang from the most proximal and distal screw.Although the root cause cannot be determined definitively, it is possible that, even with successful fusion, the implanted construct was subjected to regular bio-mechanical loading over the five years post-op that resulted in the screw disengagement of the mesa screws at the screw/rod interface.

• Brand Name: FOUNDATION SCREW; SIZE 6.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9242126
• Report Number: 3004774118-2019-00130
• Device Sequence Number: 16219837
• Product Code: NKB
• UDI-Device Identifier: 10888857136175
• UDI-Public: 10888857136175
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2020

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: 801-06545D
• Device Catalogue Number: 801-06545D
• Device Lot Number: CFMGA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 12/30/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/07/2019; 07/30/2020
• 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
• Patient Age: 20 YR