MAUDE Adverse Event Report: K2M, INC. DEFORMITY, UNIPLANAR SCREW; SIZE Ø5.5X30 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-35530
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
It was reported that mesa rail rods slipped from mesa uniplanar screws at t3 post-operatively.Plans for revision surgery are not known at this time.No adverse consequences were reported.This record captures the second of the two mesa uniplanar screws.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device remains implanted in the patient.Device history records and complaint history could not be reviewed as the device lot number was not provided.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.According to the mesa surgical technique guide, patient trauma post-op or high activity level can introduce unanticipated loading to the construct, leading to the axial slip along the rod.According to the ifu, these 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.It is unknown if there were any complications during the initial surgery.A minimum of 3 follow up attempts were performed to obtain additional information; however, a response was not received.From the available information, an exact cause of the reported event could not be determined.
Event or Problem Description
It was reported that mesa rail rods slipped from mesa uniplanar screws at t3 post-operatively.Plans for revision surgery are not known at this time.No adverse consequences were reported.This record captures the second of the two mesa uniplanar screws.

• Brand Name: DEFORMITY, UNIPLANAR SCREW; SIZE Ø5.5X30 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: 12360360
• Report Number: 3004774118-2021-00261
• Device Sequence Number: 3794341
• Product Code: NKB
• UDI-Device Identifier: 10888857049864
• UDI-Public: 10888857049864
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2021

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: 3001-35530
• Device Catalogue Number: 3001-35530
• Device Lot Number: UNKNOWN
• 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: 07/26/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 12/08/2021
• 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: Male