MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW INSERTER; EVEREST; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number	2901-N90098-B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot jcvx (1): manufacture date 11 april 2019.Device returned 17 november 2022.
Event or Problem Description
This record is a consolidation of q4 2022 records summarized as a part of the fda voluntary malfunction summary reporting program.This report captures one instance of intraoperative everest locking screw inserter tip deformation.

• Brand Name: LOCKING SCREW INSERTER; EVEREST
• Common Device Name: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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: 16264994
• Report Number: 3004774118-2023-00008
• Device Sequence Number: 19917915
• Product Code: OLO
• UDI-Device Identifier: 10888857405486
• UDI-Public: 10888857405486
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181890
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2023

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: 2901-N90098-B
• Device Catalogue Number: 2901-N90098-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/01/2023
• Initial Report FDA Received Date: 01/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2019
• 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