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

Model Number	208-42F42
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported a pyrenees constrained two-level plate fractured approximately two-years after implantation.The device remains implanted and it is unknown if revision surgery is planned.
Additional Manufacturer Narrative
Corrected data: the original surgery was in (b)(6) 2019.Visual analysis: upon inspection of the provided image, it was observed that the fracture occurred mid-plate, spanning across two screw holes.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The device fractured over one year post-operatively.Pseudoarthrosis or long-term loading may have contributed to the failure.It could not be confirmed from the provided image if fusion was achieved.From the pyrenees surgical technique, incidence of pseudoarthrosis could allow for continued dynamic motion within the construct, which may contribute to a failure of this nature.According to the surgical technique, 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.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.However, as the device was not available for evaluation, this cause could not be determined conclusively.H3 other text : device remains implanted in patient.
Event or Problem Description
A physician reported a pyrenees constrained two-level plate fractured approximately two-years after implantation.The device remains implanted and it is unknown if revision surgery is planned.

• Brand Name: CONSTRAINED 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: 11396804
• Report Number: 3004774118-2021-00062
• Device Sequence Number: 14298260
• Product Code: KWQ
• UDI-Device Identifier: 10888857030961
• UDI-Public: 10888857030961
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K063544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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: 208-42F42
• Device Catalogue Number: 208-42F42
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 05/30/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1