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

Model Number	101-10001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that a patient was experiencing "mild pain in the operated area" approximately five months after implant surgery.X-ray imaging indicated migration of a denali set screw has occurred.There are no plans for revision surgery at this time.
Event or Problem Description
It was reported that a patient was experiencing "mild pain in the operated area" approximately five months after implant surgery.X-ray imaging indicated migration of a denali set screw has occurred.There are no plans for revision surgery at this time.
Additional Manufacturer Narrative
Corrected data: b.1.And b.2.Have been corrected to reflect malfunction.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It could not be determined if the set screw was placed with sufficient torque or if the rod was fully reduced.This may have led to sub-optimal engagement between the set screw and the rod, which may have contributed to loosening and eventually disengagement.It is also possible that post-operative patient activities introduced unanticipated loading within the construct, which may have caused the set screw to back out, allowing the rod to disengage from the screw.However, the cause of the failure could not be determined conclusively.

• 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: 10124109
• Report Number: 3004774118-2020-00109
• Device Sequence Number: 14138554
• 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
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2021

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: HUJM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 02/22/2021
• 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: Other