MAUDE Adverse Event Report: K2M, INC. DEFORMITY POLYAXIAL SCREW; SIZE Ø5.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	3001-05550
Medical Device Problem Codes	Migration (4003); Premature Separation (4045)
Health Effect - Clinical Codes	No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
Event or Problem Description
On (b)(6) 2018 it was reported to k2m, inc.That a patient presented with a possible screw disengagement from rod approximately 6 weeks post-operatively.
Event or Problem Description
This report is being submitted retrospectively per fda request.Report was initially reported as 3004774117-2018-00120.It was reported that a patient presented with a possible screw disengagement from rod approximately 6 weeks post-operatively.The device remains implanted.
Additional Manufacturer Narrative
This report is being submitted retrospectively per fda request.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE Ø5.5X50 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 karen ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7773915
• Report Number: 3004774118-2018-00120
• Device Sequence Number: 1431615
• Product Code: NKB
• UDI-Device Identifier: 10888857046764
• UDI-Public: 10888857046764
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: 3001-05550
• Device Catalogue Number: 3001-05550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 08/10/2018
• Supplement Report FDA Received Date: 07/13/2023
• 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: Unknown