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

Model Number 3001-05550

Device Problems Migration (4003); Premature Separation (4045)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2018

Event Type  malfunction  

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 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 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.

Manufacturer Narrative

This report is being submitted retrospectively per fda request.

• Brand Name: DEFORMITY POLYAXIAL SCREW; SIZE Ø5.5X50 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 karen ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 7773915
• MDR Text Key: 117283936
• Report Number: 3004774118-2018-00120
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857046764
• UDI-Public: 10888857046764
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3001-05550
• Device Catalogue Number: 3001-05550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/10/2018
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 07/13/2023
• 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