MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.5X16 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04516DA
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while inserting an ozark self-starting variable screw into an ozark plate, a sliver piece of metal came out through the plate window as the screw was driven deeper.The procedure was completed successfully without surgical delay.No adverse consequences were reported.This record captures the ozark self-starting variable screw.
Additional Manufacturer Narrative
A visual inspection was performed which confirmed the ozark screw did fracture.The threading was returned as 2 fragments.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, no similar complaints were identified.Due to screw main body and associated plate not being able to be returned, a definitive root cause could not be determined.Based on screw thread fragments returned, the most potential root cause may be screw over angulation, however this cannot be confirmed.Screw over angulation may cause screw thread to contact plate during insertion and strip the threads.
Event or Problem Description
It was reported that while inserting an ozark self-starting variable screw into an ozark plate, a sliver piece of metal came out through the plate window as the screw was driven deeper.The procedure was completed successfully without surgical delay.No adverse consequences were reported.This record captures the ozark self-starting variable screw.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.5X16 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: 12812679
• Report Number: 3004774118-2021-00357
• Device Sequence Number: 20220837
• Product Code: KWQ
• UDI-Device Identifier: 10888857393721
• UDI-Public: 10888857393721
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• 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): 02/23/2022

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: 8801-04516DA
• Device Catalogue Number: 8801-04516DA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 01/26/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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