MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; SIZE 4.0X20 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-04020M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
It was reported that two yukon polyaxial screws fractured at t1, about 5 months post-operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.This record captures the first of the two reported yukon polyaxial screws.
Additional Manufacturer Narrative
It was reported that the patient was implanted with a yukon oct system construct from c3 to t1, on (b)(6) 28, 2021.Screw fractures were noticed at t1 during a follow-up x-ray.Visual, dimensional, functional and material analysis could not be performed as the device remains implanted in the patient.Device history records and complaint history could not be reviewed as the lot number was not provided.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.According to the yukon 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.Loads produced by load bearing and activity levels will impact the longevity of the implant.Correspondence with company representative states that the patient's activity level is unknown, the patient did not fall after the initial surgery, and fusion was not achieved.An exact cause of the event could not be determined.Potential causes include: patient performs high activity level, unstable initial construct, etc.
Event or Problem Description
It was reported that two yukon polyaxial screws fractured at t1, about 5 months post- operatively.No adverse consequences were reported.Revision surgery has not been performed nor scheduled at this time.This record captures the first of the two reported yukon polyaxial screws.

• Brand Name: POLYAXIAL SCREW ML; SIZE 4.0X20 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11967742
• Report Number: 3004774118-2021-00172
• Device Sequence Number: 3789646
• Product Code: NKG
• UDI-Device Identifier: 10888857350397
• UDI-Public: 10888857350397
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/08/2021

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: 7601-04020M
• Device Catalogue Number: 7601-04020M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1