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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A physician reported that a pyrenees plate fractured approximately 4 to 6 months after implantation.The physician is not planning revision surgery at this time.
Additional Manufacturer Narrative
Visual analysis: the device was not available for evaluation as it remains implanted in the patient.However, x-rays were provided by the rep.Upon review, it appears that the plate fractured through the central screw holes.Dimensional, functional, and material analysis could not be performed as the device remains implanted in the patient.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.The pyrenees constrained & translational cervical plates surgical technique was reviewed and the following relevant information was identified: the physician should 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.It was reported that fusion had not yet been achieved.Pseudoarthrosis may have contributed to the failure.
Event or Problem Description
A physician reported that a pyrenees plate fractured approximately 4 to 6 months after implantation.The physician is not planning revision surgery at this time.

• 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: 9372927
• Report Number: 3004774118-2019-00152
• Device Sequence Number: 2708970
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 01/26/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1