MAUDE Adverse Event Report: K2M, INC. FENESTRATED, POLYAXIAL SCREW; SIZE Ø6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	F2911-06540-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest fenestrated screw fractured at s1 post-operatively.The physician indicates revision surgery is not required.
Additional Manufacturer Narrative
Devices remains implanted.
Additional Manufacturer Narrative
Product inspections could not be performed as the product is still implanted in the patient and is therefore unavailable for evaluation.However, an x-ray was provided and reviewed.The construct was a 2 level system with an interbody device.The screw implanted at s1 on the left side was highlighted in the x-ray.Although a clear fracture site cannot be observed, there does appear to be a slight bend in the shaft of the screw.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.The everest instructions for use states: "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.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 re-fracture 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." additional information regarding the patient's condition is unavailable at this time.As the screw has been implanted for approximately 1 year, the most likely root cause for the screw fracture can be attributed to material fatigue over time.
Event or Problem Description
It was reported that an everest fenestrated screw fractured at s1 post-operatively.The physician indicates revision surgery is not required.

• Brand Name: FENESTRATED, POLYAXIAL SCREW; SIZE Ø6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE 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: 14700025
• Report Number: 3004774118-2022-00237
• Device Sequence Number: 5327043
• Product Code: NKB
• UDI-Device Identifier: 10888857262195
• UDI-Public: 10888857262195
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K161369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: F2911-06540-G1
• Device Catalogue Number: F2911-06540-G1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 09/12/2022
• 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
• Patient Sex: Female