MAUDE Adverse Event Report: K2M, Inc. OZARK View Variable Screw, Self -Tapping Ø4.0x12 mm; Appliance, Fixation, Spinal Intervertebral Body

Catalog Number	8801-04012CA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/20/2026
Type of Reportable Event	Serious Injury

• Brand Name: OZARK View Variable Screw, Self -Tapping Ø4.0x12 mm
• Common Device Name: Appliance, Fixation, Spinal Intervertebral Body
• Manufacturer (Section D): K2M, Inc.; 600 hope pkwy; leesburg VA 20175
• Manufacturer (Section G): K2M, Inc.; 600 hope pkwy se; leesburg VA 20175
• Manufacturer Contact: catherine devarenne ; 2 pearl court; allendale, NJ 07401 ; +1(201)760-8000
• MDR Report Key: 50809846
• Report Number: 3004774118-2026-00245
• Device Sequence Number: 10589937
• Product Code: KWQ
• UDI-Device Identifier: 10888857392830
• UDI-Public: 10888857392830
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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 Catalogue Number: 8801-04012CA
• Device Lot Number: XHEJ
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/02/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown