MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
A physician reported a fractured yukon polyaxial screw post-operatively.The patient has reported "hearing a clicking noise periodically." revision surgery is not planned at this time.
Additional Manufacturer Narrative
X-rays have been received.H3 other text : device remains implanted in patient.
Event or Problem Description
A physician reported a fractured yukon polyaxial screw post-operatively.The patient has reported "hearing a clicking noise periodically." revision surgery is not planned at this time.
Event or Problem Description
A physician reported a fractured yukon polyaxial screw post-operatively.The patient has reported "hearing a clicking noise periodically." revision surgery is not planned at this time.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot number could not be obtained as the device remains implanted in the patient.The yukon oct surgical technique was reviewed and the following relevant information was identified: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; infections possibly requiring removal of devices; palpable components, painful bursa, and/or pressure necrosis; and allergies, and other reactions to device materials which, although infrequent, should be considered, tested for (if applicable), and ruled out preoperatively.Since the device was not returned, an exact cause of the reported event could not be determined.Potential causes include: patient fall, patient bone quality, excess post-op activity, overload on construct, etc.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10701606
• Report Number: 3004774118-2020-00238
• Device Sequence Number: 3258833
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/24/2021

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: 7601-05030
• Device Catalogue Number: 7601-05030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/04/2020; 02/26/2021
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/05/2020; 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR