MAUDE Adverse Event Report: K2M, INC. UNIPLANAR SCREW; SIZE Ø5.5X40 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	2911-35540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device location unknown.
Event or Problem Description
Through clinical survey, a physician reported that a patient was revised to remove loose hardware.The patient underwent a ct scan approximately 12-months postoperatively and two everest uniplanar screws on the left side at l1 and l2 were seen to have migrated.During explant surgery, the physician noted that the patient's fusion was "rock solid" and there was no need to replace the instrumentation.This report captures the second of two migrated everest uniplanar screws.
Additional Manufacturer Narrative
The devices were not returned and therefore unavailable for evaluation.Device history records and complaint history could not be reviewed without either the device or a valid lot number.The surgeon confirmed that the patient had fully fused.The patient was not experiencing any adverse effects from the loose hardware, but requested it be removed.The patient underwent revision surgery to remove the implants and, following the device removal, the patient experienced a post-operative seroma which improved.Five-month and twelve-month post-operative scans were available through stryker's medidata platform.No visible screw migration/pull-out was observed.It is suspected that the reported "screw loosening" may be referencing the unintended movement of the uniplanar head(s).Once implanted and final tightened, the everest screw head is intended to fixate in its position relative to the screw shaft.If the implanted device experiences an external trauma, the angulation between the screw head and shaft can adjust.It was reported that the patient fell twice within 3 months after the index surgery.This unexpected force may have dislodged the tulip's from their intended position.The surgeon reported that the bone fusion was observed to be stable during device explant.The everest spinal system instructions for use states: "metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.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 benefits when deciding whether to remove the implant implant removal should be followed by adequate postoperative management to avoid refracture." in this case, the patient had fully fused and the screw provided the temporary stabilization needed during healing.Therefore, potential root causes for the tulip positioning issue reported could be attributed to the patient fall(s) following the index surgery, or normal implant wear over time, as the implants are load-sharing devices which maintained alignment until healing occurred.However, as the devices were not returned for evaluation, the failure mode could not be confirmed.
Event or Problem Description
Through clinical survey, a physician reported that a patient was revised to remove loose hardware.The patient underwent a ct scan approximately 12-months postoperatively and two everest uniplanar screws on the left side at l1 and l2 were seen to have migrated.During explant surgery, the physician noted that the patient's fusion was "rock solid" and there was no need to replace the instrumentation.This report captures the second of two migrated everest uniplanar screws.

• Brand Name: UNIPLANAR SCREW; SIZE Ø5.5X40 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: 13971649
• Report Number: 3004774118-2022-00122
• Device Sequence Number: 4524193
• Product Code: NKG
• UDI-Device Identifier: 10888857044012
• UDI-Public: 10888857044012
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181603
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: 2911-35540
• Device Catalogue Number: 2911-35540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/03/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 07/06/2022
• 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 Sex: Male