MAUDE Adverse Event Report: K2M, INC. SCREW, SELF STARTING; SIZE Ø5.0X40 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	4501-15040
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that approximately two months post-operatively a cayman self-starting screw migrated.Revision surgery has not been performed.
Additional Manufacturer Narrative
H6: coding has been updated to reflect investigation conclusion h3 other text: device remains implanted.
Event or Problem Description
It was reported that approximately two months post-operatively a cayman self-starting screw migrated.Revision surgery has not been performed.

• Brand Name: SCREW, SELF STARTING; SIZE Ø5.0X40 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: 18277116
• Report Number: 3004774118-2023-00166
• Device Sequence Number: 15143957
• Product Code: KWQ
• UDI-Device Identifier: 10888857093119
• UDI-Public: 10888857093119
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Catalogue Number: 4501-15040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 03/06/2024
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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