MAUDE Adverse Event Report: K2M, INC. PLATE, 3 LEVEL; SIZE 63 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-43F63V
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bottom locking mechanism of an ozark 3 level plate 'popped off' approximately 5 months post-operatively.The plate remains implanted in the patient, revision surgery has not been scheduled or performed.
Additional Manufacturer Narrative
Devices remains implanted.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device remains implanted in the patient.However, an x-ray was provided that confirms the most caudal securing mechanism has disengaged from the plate.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no adverse trends were identified.It was reported via follow up communication that there is no plan to revise the patient as they have fused and are not experiencing any pain.The associate screws have not migrated.Screw holes were prepped with ozark 2.3 x12 mm drill bit.Size 10 tapered driver with ao handle was used to insert the screws.Screws were not inserted at a difficult angle and there was no issues locking the securing mechanism.Patient had mediocre bone quality, was compliant post-op, and did not experience a fall/trauma.Due to no product return the root cause could not be determined conclusively.X-ray review indicates the screws may have been over angulated based on the post-event x-ray.However, this cannot be definitely confirmed without immediate post-op x-rays or product return.Over angulation of caudal screws can interfere with the ability of the securing mechanism to lock correctly and can exert higher than intended forces on the securing mechanism post-op.Additionally, patients 'mediocre' bone quality may have potentially contributed to the event but no subsidence is noted in x-ray.
Event or Problem Description
It was reported that the bottom locking mechanism of an ozark 3 level plate 'popped off' approximately 5 months post-operatively.The plate remains implanted in the patient, revision surgery has not been scheduled or performed.

• Brand Name: PLATE, 3 LEVEL; SIZE 63 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: 14658487
• Report Number: 3004774118-2022-00231
• Device Sequence Number: 14431752
• Product Code: KWQ
• UDI-Device Identifier: 10888857402065
• UDI-Public: 10888857402065
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2022

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: AA01-43F63V
• Device Catalogue Number: AA01-43F63V
• 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: 05/13/2022
• Supplement Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 09/07/2022
• 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 Age: 48 YR
• Patient Sex: Female