MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 40 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-42F40V
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that an ozark view 2 level plate locking cover failed 6 weeks post-operatively.Revision surgery was performed.
Additional Manufacturer Narrative
Visual inspection: the device was inspected and found to be in fair condition with general signs of wear.The screw cover showed signs of plastic deformation as the cover appears to have been lifted away from the plate.It appears that some deformation may have occurred within the screw cover (possibly to the stem) which has allowed the cover to spin freely.Analysis of the plate suggests that the subject screw cover was not overturned as there were no deformities observed on the stops.Functional inspection: the device was tested by engaging all screw covers.Upon review, it was found that the cranial screw cover was loose and unable to stay in a set position.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Investigation could not confirm if external factors (fall, trauma) could have contributed to the issue, and a root cause for the issue was unable to be determined.
Event or Problem Description
A physician reported that an ozark view 2 level plate locking cover failed 6 weeks post-operatively.Revision surgery was performed.

• Brand Name: PLATE, 2 LEVEL; SIZE 40 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9734816
• Report Number: 3004774118-2020-00018
• Device Sequence Number: 11593318
• Product Code: KWQ
• UDI-Device Identifier: 10888857401594
• UDI-Public: 10888857401594
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2020

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: AA01-42F40V
• Device Catalogue Number: AA01-42F40V
• Device Lot Number: JDYC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 07/22/2020
• 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