MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 36 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-42F36V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the locking mechanism of an ozark 2 level plate at c7 fractured off approximately 17 months post operatively.The patient was revised and the plate was explanted.
Event or Problem Description
It was reported that the locking mechanism of an ozark 2 level plate at c7 fractured off approximately 17 months post operatively.The patient was revised and the plate was explanted.
Additional Manufacturer Narrative
The device was visually inspected and was confirmed to have had a broken off locking mechanism.The locking mechanism at the caudal end of the plate had fractured and separated off.Device and complaint history records were reviewed for this lot, no manufacturing issues or similar complaints were identified.It is not clear what may have caused the issue to occur, although it is possible that pseudoarthrosis had contributed to the issue.If arthrodesis of the spine is not properly achieved then the construct could be subjected to damaging loads.It is possible that the locking mechanism was subjected to a damaging load which caused the component to fracture and break off from the device.However, this potential failure mode was unable to be properly evaluated, and a cause for the issue was unable to be determined.

• Brand Name: PLATE, 2 LEVEL; SIZE 36 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10759839
• Report Number: 3004774118-2020-00291
• Device Sequence Number: 3840916
• Product Code: KWQ
• UDI-Device Identifier: 10888857401556
• UDI-Public: 10888857401556
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AA01-42F36V
• Device Catalogue Number: AA01-42F36V
• Device Lot Number: GRPA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 01/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention