MAUDE Adverse Event Report: K2M, INC. PLATE, 3 LEVEL; SIZE 54 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-43F54V
Medical Device Problem Codes	Fracture (1260); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Current location of the device is unknown.
Event or Problem Description
A physician reported two ozark screws backed out of an ozark plate at c7 approximately five-months post-operatively.The patient is scheduled for revision surgery.This report captures the ozark plate with a disengaged securing mechanism.
Additional Manufacturer Narrative
The device was not returned for evaluation.The reported securing mechanism fracture and screw migrations was confirmed through inspection of the associated radiographic image.The construct was composed of a three (3) level plate, six (6) screws, and interbody spacers.Both screws at the caudal-most level of the construct migrated from the plate.A review of manufacturing history could be not performed as the subject lot number could not be identified.Complaint history was reviewed for the corresponding catalog number and no adverse trends were identified.Correspondence with field representative states that the patient was implanted with hardware on (b)(6) 2020.The patient allegedly experienced external trauma (fall), and the screw migration and securing mechanism fracture were observed subsequently.According to the ozark surgical technique, instantaneous loading due to patient activity can cause the implant could break, bend, or loosen.The most likely root cause of the reported event is post-operative trauma (patient fall).H3 other text: device not returned for evaluation.
Event or Problem Description
A physician reported two ozark screws backed out of an ozark plate at c7 approximately five-months post-operatively.The patient has been revised.This report captures the ozark plate with a disengaged securing mechanism.

• Brand Name: PLATE, 3 LEVEL; SIZE 54 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11310132
• Report Number: 3004774118-2021-00039
• Device Sequence Number: 17153048
• Product Code: KWQ
• UDI-Device Identifier: 10888857401976
• UDI-Public: 10888857401976
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: AA01-43F54V
• Device Catalogue Number: AA01-43F54V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 05/28/2021
• 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