MAUDE Adverse Event Report: K2M, INC. SET SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-10001
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device retained by hospital.
Event or Problem Description
A company representative reported that four yukon polyaxial screws migrated from c4 and c5 and the yukon set screws at c2 did not retain the rods.The patient has reported experiencing pain and revision surgery is scheduled.This report captures the second of two yukon set screws.
Additional Manufacturer Narrative
The device was not returned for evaluation but the reported event was confirmed via visual analysis of x-ray images.Device history records could not be reviewed without either the device or a valid lot number.Complaint history was reviewed and no similar complaints for the reported catalogue number were identified.A conclusive root cause could not be determined with the available information.However, from analyzing the provided x-ray, the following was determined to be the probable sequence of events: rods slide out of saddle of upper c2 screws due to loose set screws.Spine falls forward with gravity due to loss of fixation at cranial end of construct.Screws migrate out of the bone due to weakness of cervical spine bone and the fixation strength of the lateral mass screws to into that bone.A root cause could not be conclusively determined, and there may have been multiple contributing factors including, but not limited to: set screws over-tightened (damage to set screws leaves insufficient material to secure rod).Set screws under-tightened (rod not secured in place).Rod not reduced correctly (rod not fully/evenly seated in tulip head).Rod cut too short (rod not be fully secured/set screw not fully engaged with rod).Patient factors (e.G., smoking, obesity, age, post-operative activity, etc.Can affect bone quality, duration to fusion, patient falls, etc.).
Event or Problem Description
A company representative reported that four yukon polyaxial screws migrated from c4 and c5 and the yukon set screws at c2 did not retain the rods.The patient has reported experiencing pain and revision surgery is scheduled.This report captures the second of two yukon set screws.

• Brand Name: SET SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 14115657
• Report Number: 3004774118-2022-00145
• Device Sequence Number: 12201248
• Product Code: NKG
• UDI-Device Identifier: 10888857328310
• UDI-Public: 10888857328310
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7601-10001
• Device Catalogue Number: 7601-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female