MAUDE Adverse Event Report: K2M, INC. SCREW; SIZE Ø6.0X22 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	1201-16022
Medical Device Problem Codes	Difficult to Insert (1316); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a cayman anterior screw, "continued to spin and not lock into the plate," during surgery.The doctor attempted implantation with a second cayman anterior screw but could not get enough purchase in the bone.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.Inspection of the returned devices identified deformation on the threading of the screws.This report captures the first cayman anterior screw.
Additional Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
A company representative reported that a cayman anterior screw, "continued to spin and not lock into the plate," during surgery.The doctor attempted implantation with a second cayman anterior screw but could not get enough purchase in the bone.The procedure was completed successfully with no surgical delay and no adverse consequence to the patient.Inspection of the returned devices identified deformation on the threading of the screws.This report captures the first cayman anterior screw.

• Brand Name: SCREW; SIZE Ø6.0X22 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 15761378
• Report Number: 3004774118-2022-00386
• Device Sequence Number: 15509130
• Product Code: KWQ
• UDI-Device Identifier: 10888857018587
• UDI-Public: 10888857018587
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081380
• 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): 01/31/2023

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: 1201-16022
• Device Catalogue Number: 1201-16022
• Device Lot Number: PFTF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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
• Patient Sex: Unknown