MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	101-06545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Stryker was provided with two possible catalogue / lot numbers for the fractured device: 101-06545 / hufu or 101-06540 / fdkw.If we receive additional clarifying information, the catalogue / lot number will be corrected in our next report.H3 other text : device location unknown.
Event or Problem Description
It was reported that a denali polyaxial screw fractured several months after implantation.Revision status is unknown.
Additional Manufacturer Narrative
Corrected data: b5.Additional data: d6b, h4.
Event or Problem Description
It was reported that approximately four months post-operatively a patient was revised to address the fracture of a denali polyaxial screw.

• Brand Name: POLYAXIAL SCREW; SIZE Ø6.5X45 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: 18460525
• Report Number: 3004774118-2024-00002
• Device Sequence Number: 17921470
• Product Code: NKB
• UDI-Device Identifier: 10888857002777
• UDI-Public: 10888857002777
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Catalogue Number: 101-06545
• Device Lot Number: HUFU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/05/2024
• Supplement Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2019
• 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: Unknown