MAUDE Adverse Event Report: K2M, INC. DRIVER; SIZE 8; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number	7012-90095
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that two mojave pl drivers stripped post-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report is for the second of the two drivers.
Additional Manufacturer Narrative
Inspection of the device and additional review of the events indicates this incident to be non-reportable.The event caused no serious deterioration in the state of health of a patient or user.Review of product and complaint history indicates that no prior similar incidents have led to a serious deterioration in the past, nor is a recurrence of this incident likely to lead to a serious deterioration in the future.
Event or Problem Description
A company representative reported that two mojave pl drivers stripped post-operatively.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.This report is for the (b)(4) drivers.

• Brand Name: DRIVER; SIZE 8
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• 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: 15029387
• Report Number: 3004774118-2022-00280
• Device Sequence Number: 6147847
• Product Code: MAX
• UDI-Device Identifier: 10888857391697
• UDI-Public: 10888857391697
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K163364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7012-90095
• Device Catalogue Number: 7012-90095
• Device Lot Number: NGTF
• 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: 06/17/2022
• Supplement Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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
• Patient Sex: Unknown