MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE Ø4.0X30 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-04030
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that slippage of the rod occurred on four mesa polyaxial screws at l4-l5 and l5-s1 post-operatively.Revision has occurred.This report will capture the second of four screws.
Event or Problem Description
It was reported that slippage of the rod occurred on four mesa polyaxial screws at l4-l5 and l5-s1 post-operatively.Revision has occurred.This report will capture the second of four screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the screw associated with this record was not returned for evaluation.It was reported that the rods slipped from the screw heads 5 months after implantation.Two of the six screws from this construct were returned and evaluated (captured in reports 3004774118-2022-00004 and 3004774118-2022-00005).Those two screws appeared to have been fully locked.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, no similar complaints were identified.X rays were provided showing a 3-level construct from l4-s1.The x rays on 17dec2021 show the rods slipped from the screw heads.The 09jul2021 index surgery shows the screws with the rod locked in with what appears to be adequate rod overhang.Rep reported that the quick locker was used and there were no issues during final locking.Patient post op activity is unknown.The mesa device ifu and surgical technique were reviewed: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; adequately instruct the patient.Postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.The mesa device ifu and surgical technique were reviewed: potential adverse events associated with spinal fusion procedures include, but are not limited to pseudoarthrosis; loosening, bending, cracking or fracture of components, or loss of fixation in the bone with possible neurologic damage, usually attributable to pseudoarthrosis, insufficient bone stock, excessive activity or lifting, or one or more of the factors listed in contraindications, or warnings and precautions; adequately instruct the patient.Postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.Based on the returned screws and x rays, the construct appeared to be fully locked and there was adequate rod overhang.No manufacturing issues were found.An exact cause cannot be determined, but based on the ifu and risk file, potential root causes include excessive patient post-op activities beyond surgeon recommendation and/or patient fall.Additionally, only 2 of the 6 screws in the construct were returned, so it was only able to be definitively determined that 2 screws were fully locked.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE Ø4.0X30 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: 13172575
• Report Number: 3004774118-2022-00006
• Device Sequence Number: 11976192
• Product Code: NKB
• UDI-Device Identifier: 10888857046184
• UDI-Public: 10888857046184
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 3001-04030
• Device Catalogue Number: 3001-04030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male