MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X24 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05024
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
It was reported that 2 yukon oct polyaxial screws at t1 broke post-operatively.Revision surgery has not been scheduled at this time.This report will capture the second of two screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.As no devices or x-rays were available, we were unable to determine the root cause conclusively.Non-union may have contributed to the failure.We were unable to confirm if fusion was achieved.According to the yukon surgical technique, these 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.Post-operative activities may have introduced unanticipated loading to the construct, resulting in fracture.
Event or Problem Description
It was reported that 2 yukon oct polyaxial screws at t1 broke post-operatively.Revision surgery has not been scheduled at this time.This report will capture the second of two screws.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X24 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11490064
• Report Number: 3004774118-2021-00077
• Device Sequence Number: 14452311
• Product Code: NKG
• UDI-Device Identifier: 10888857349995
• UDI-Public: 10888857349995
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2021

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: 7601-05024
• Device Catalogue Number: 7601-05024
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1