MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE Ø5.5X35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-05535

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 04/19/2018

Event Type  Injury  

Event Description

A patient was revised to address a migrated mesa polyaxial screw at left t12.

Manufacturer Narrative

Device location is unknown.

Manufacturer Narrative

H6 coding has been updated to reflect completion of the investigation.

Event Description

A patient was revised to address a migrated mesa polyaxial screw at left t12.

• Brand Name: POLYAXIAL SCREW; SIZE Ø5.5X35 MM
• Type of Device: 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: 15695035
• MDR Text Key: 302688391
• Report Number: 3004774118-2022-00364
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857135536
• UDI-Public: 10888857135536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 801-05535
• Device Catalogue Number: 801-05535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female