MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 7.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	2911-07550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that one everest polyaxial screw fractured and two everest polyaxial screws migrated.The patient was undergoing a revision surgery approximately one year after implantation to address non-fusion when the surgeon identified the fracture and migrations, which they attributed to the patient's pseudo-arthrosis.This report captures the fractured screw.
Additional Manufacturer Narrative
Visual inspection: the screw was returned fractured at the shank.Beach marks were observed on the fracture surface, indicating fatigue fracture.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.It was reported that the initial surgery was about a year previous and the patient had pseudoarthorosis.The surgeon believed this lead to the fractured and loose screws.From the ifu: 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.As the screw was implanted for a year and the patient was confirmed to have pseudoarthorosis, the likely cause is fatigue fracture due to the patient's delayed healing.
Event or Problem Description
A company representative reported that one everest polyaxial screw fractured and two everest polyaxial screws migrated.The patient was undergoing a revision surgery approximately one year after implantation to address non-fusion when the surgeon identified the fracture and migrations, which they attributed to the patient's pseudo-arthrosis.This report captures the fractured screw.

• Brand Name: POLYAXIAL SCREW; SIZE 7.5X50 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11678269
• Report Number: 3004774118-2021-00113
• Device Sequence Number: 19607306
• Product Code: NKB
• UDI-Device Identifier: 10888857042711
• UDI-Public: 10888857042711
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• 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): 07/23/2021

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: 2911-07550
• Device Catalogue Number: 2911-07550
• Device Lot Number: JNGF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1