MAUDE Adverse Event Report: K2M, INC. SELF-TAPPING, VARIABLE SCREW; SIZE Ø4.0X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04014CA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that at the six month follow up, one (1) ozark self-tapping, variable screw at c7 has backed out beyond the locking mechanism of the ozark plate.The patient is doing well, and a revision surgery has not been scheduled.No adverse consequences, surgical delay or medical intervention were reported.This report captures the ozark self-tapping variable screw.
Additional Manufacturer Narrative
Device remains implanted.
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 at the six month follow up, one (1) ozark self-tapping, variable screw at c7 has backed out beyond the locking mechanism of the ozark plate.The patient is doing well, and a revision surgery has not been scheduled.No adverse consequences, surgical delay or medical intervention were reported.This report captures the ozark self-tapping variable screw.

• Brand Name: SELF-TAPPING, VARIABLE SCREW; SIZE Ø4.0X14 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: 15279898
• Report Number: 3004774118-2022-00328
• Device Sequence Number: 12274307
• Product Code: KWQ
• UDI-Device Identifier: 10888857392854
• UDI-Public: 10888857392854
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 8801-04014CA
• Device Catalogue Number: 8801-04014CA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female