MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø3.5X14 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-03514
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Neuropathy (1983); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient received their initial surgery on (b)(6) 2020 where they received a posterior cervical fixation / fusion.The patient then presented with consistent myelopathy among other pain complaints in their cervical area.An extension of the posterior cervical lateral mass fusion as well laminectomy was then performed in (b)(6) 2021.During the planned revision surgery, the yukon screw at c5 which was originally implanted in (b)(6) 2020 was noticed to be fractured during removal.Half of the shaft attached to the screw head was able to be removed while the other half remains in the patient.Well established bone fusion was noted on the remaining implanted screws.
Additional Manufacturer Narrative
The device has been received and section d has been updated.B1 has been updated from 'adverse event and product problem' to 'product problem'.The returned yukon oct polyaxial screw was visually inspected.The screw was confirmed to have a main body fracture.The fracture occurred at approximately the mid-point of the threaded shaft.The tulip head was stuck in its implanted position, with the head posed according to patient anatomy and the construct.Device and complaint history records were reviewed for this lot, no relevant manufacturing issues or similar complaints were identified.Once a screw is implanted and final tightened, the friction-fit apposable head locks into place to prevent construct movement post-operatively.It was reported that the screw fractured during attempts at re-positioning the tulip for the new construct.The bending load applied using the alignment tool may have caused the screw to fracture.In addition, the patient had fully fused and had been implanted with the screw for over a year.The yukon oct spinal system ifu states that, "the k2m spinal implants are intended to provide temporary stabilization.If an implant remains implanted after complete healing it can actually increase the risk of refracture in an active individual.The surgeon should weigh the risks versus the benefits when deciding whether to remove the implant." implanted screws are load sharing devices that may fracture after patient healing occurs.The device was subject to normal wear while implanted for over a year, followed by an applied axial force intra-operatively.Therefore, the most likely root cause for the reported event is due to normal device wear.
Event or Problem Description
It was reported that a patient presented with consistent myelopathy among other pain complaints in their cervical area.An extension of the posterior cervical lateral mass fusion as well laminectomy was performed.During the planned revision surgery, the yukon screw at c5 which was originally implanted 2020 was noticed to be fractured during removal.Half of the shaft attached to the screw head was able to be removed while the other half remains in the patient.

• Brand Name: POLYAXIAL SCREW; SIZE Ø3.5X14 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: 13047668
• Report Number: 3004774118-2021-00407
• Device Sequence Number: 3888690
• Product Code: NKG
• UDI-Device Identifier: 10888857349315
• UDI-Public: 10888857349315
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 7601-03514
• Device Catalogue Number: 7601-03514
• Device Lot Number: HTJF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 03/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2019
• 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; Other
• Patient Age: 53 YR
• Patient Sex: Male