MAUDE Adverse Event Report: K2M, INC. TORQUE LIMITING HANDLE; 2.2N-M; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	7601-90138
Medical Device Problem Codes	Calibration Problem (2890); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Two yukon torque limiting handles which were used in two implant surgeries which resulted in implant migration require functional and calibration checks.This report captures the first of two torque limiting handles.
Additional Manufacturer Narrative
Correction: an updated review of the event information does not suggest that this event is a serious injury.The reported implant migration has been captured in manufacturing reports 3004774118-2024-00035, 3004774118-2024-00036, 3004774118-2024-00100, 3004774118-2024-00101, and 3004774118-2024-00102.A review of the risk documentation regarding this event does not suggest a recurrence of this event could result in a death or serious injury.Therefore, this event is no longer reportable to the fda.H6 codes have been updated to reflect conclusion of the investigation.Event is no longer reportable.
Event or Problem Description
Two yukon torque limiting handles which were used in two implant surgeries which resulted in implant migration require functional and calibration checks.This report captures the first of two torque limiting handles.

• Brand Name: TORQUE LIMITING HANDLE; 2.2N-M
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 19509659
• Report Number: 3004774118-2024-00038
• Device Sequence Number: 11614190
• Product Code: LXH
• UDI-Device Identifier: 10888857384194
• UDI-Public: (01)10888857384194(11)220822(10)VNTV
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2024

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: Health Professional
• Device Catalogue Number: 7601-90138
• Device Lot Number: VNTV009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 10/25/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown