MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø7.5X40 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	2911-07540
Medical Device Problem Codes	Positioning Problem (3009); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was revised approximately two weeks after implantation to address two everest polyaxial screws at s1 which, "lost their fixation." this report captures the second of two screws.
Additional Manufacturer Narrative
The returned everest polyaxial screw was inspected visually and functionally.The proximal end of the screw shank, where the tulip head mates, showed signs of deformation.It is suspected that these deformations indicate the angle the tulip head was positioned when the construct was final tightened.The tulip head was moveable with slight resistance.The design of the anvil component of the screw head consists of two leaf springs, which produce the friction between the screw head and the proximal end of the screw shank.If the springs become deformed or disengaged from the proximal end of the screw shank, the polyaxiality of the screw head can become compromised.Device and complaint history records were reviewed for this lot and catalog number, no relevant manufacturing issues or adverse trends were identiifed.The everest spinal system instructions for use states: "k2m spinal systems are contraindicated in the presence of.Obesity," as well as, "patient selection and compliance is extremely important.Based on fatigue testing results, the k2m everest® spinal system has been determined to be substantially equivalent to predicate devices however, the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient conditions, etc , which may impact on the performance of this system.Spinal implant surgery on patients with conditions listed under contraindications may not be candidates for this procedure".As the patient in the event was determined to be obese, the most likely root cause for the reported event can be attributed to use of the device against the ifu.
Event or Problem Description
A patient was revised approximately two weeks after implantation to address two everest polyaxial screws at s1 which, "lost their fixation." this report captures the second of two screws.
Additional Manufacturer Narrative
The device has been received and fields d4 and d9/h3 have been updated.
Event or Problem Description
A patient was revised approximately two weeks after implantation to address two everest polyaxial screws at s1 which, "lost their fixation.".This report captures the second of two screws.

• Brand Name: POLYAXIAL SCREW; SIZE Ø7.5X40 MM
• 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: 14633140
• Report Number: 3004774118-2022-00220
• Device Sequence Number: 20364989
• Product Code: NKG
• UDI-Device Identifier: 10888857042674
• UDI-Public: 10888857042674
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2022

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: 2911-07540
• Device Catalogue Number: 2911-07540
• Device Lot Number: JRTA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 06/30/2022; 08/09/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 07/29/2022; 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• 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 Sex: Unknown
• Patient Weight: 105 KG