MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 3.5X28 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-03528
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Functional, dimensional, and material analysis could not be performed as the device remains implanted in the patient.However, x-rays were provided and upon review, it was observed that a screw, implanted at the most proximal end of the construct, was fractured immediately below the screw head.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.As the subject screw was not available for evaluation, the root cause could not be determined conclusively.Non-union may have contributed to the failure, however, based on the radiological image, it could not be determined if fusion was achieved.
Event or Problem Description
It was reported that a yukon oct polyaxial screw fractured post-operatively.The patient has not shown any symptoms and there are no plans for revision surgery at this time.
Additional Manufacturer Narrative
Functional, dimensional, and material analysis could not be performed as the device was not available because it remains implanted in the patient.However, x-rays were provided and upon review it was observed that a screw, implanted at the most proximal end of the construct, was fractured immediately below the screw head.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.As the subject screw was not available for evaluation, the root cause could not be determined conclusively.
Event or Problem Description
It was reported that a yukon oct polyaxial screw fractured post-operatively.The patient has not shown any symptoms and there are no plans for revision surgery at this time.

• Brand Name: POLYAXIAL SCREW; SIZE 3.5X28 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10277153
• Report Number: 3004774118-2020-00144
• Device Sequence Number: 11370823
• Product Code: NKG
• UDI-Device Identifier: 10888857349384
• UDI-Public: 10888857349384
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• 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): 08/11/2020

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: 7601-03528
• Device Catalogue Number: 7601-03528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 07/15/2020
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1