MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 42 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-42F42V
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/16/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
A physician reported that a patient underwent revision surgery to address two fractured ozark screws at c5 and a two-level ozark plate with a fractured securing mechanism.This report captures the two-level ozark plate.
Additional Manufacturer Narrative
Visual inspection: the device was inspected, and it was observed that one of the lateral dual screw covers had fractured immediately inferior to the hexalobe feature.Analysis of the plate suggests that the subject screw cover was not overturned as there were no deformities observed on the stops.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.The ozark guide and view surgical technique was reviewed and the following relevant information was identified: it is the physician's responsibility to adequately instruct the patient that postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.Internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Loads produced by load bearing and activity levels will impact the longevity of the implant.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus benefits when deciding whether to remove the implant.Implant removal should be followed by adequate postoperative management to avoid refracture.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.As the incident occurred approximately four months after the index surgery, it is possible that non-union contributed to the failure.Non-union could allow for continued dynamic motion within the construct, eventually causing the screw cover to fracture.It is possible that the screw cover breakage allowed the screws to migrate out of the plate and ultimately fracture under normal load bearing.
Event or Problem Description
A physician reported that a patient underwent revision surgery to address two fractured ozark screws at c5 and a two-level ozark plate with a fractured securing mechanism.This report captures the two-level ozark plate.

• Brand Name: PLATE, 2 LEVEL; SIZE 42 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9915921
• Report Number: 3004774118-2020-00063
• Device Sequence Number: 690404
• Product Code: KWQ
• UDI-Device Identifier: 10888857401617
• UDI-Public: 10888857401617
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2020

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: AA01-42F42V
• Device Catalogue Number: AA01-42F42V
• Device Lot Number: HVGR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/20/2020
• 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