MAUDE Adverse Event Report: K2M, INC. OZARK SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number UNK_SPE

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2021

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.

Event Description

A company representative reported an unspecified failure of an ozark screw and/or plate.The patient has not been revised.This report captures an ozark screw.

Manufacturer Narrative

The device was not returned for evaluation.Device history records and complaint history could not be reviewed without either the device or a valid lot number.Because the device was not returned for evaluation, the root cause could not be determined conclusively.According to the surgical technique, potential root causes include: incorrect depth, trajectory, alignment, positioning, lock-unlock setting, assembly of instruments-implants.Too much or too little mechanical energy (axial, insertion, removal, compressive, torque, cantilever).Hard bone quality.

Event Description

A company representative reported an unspecified failure of an ozark screw and/or plate.The patient has not been revised.This report captures an ozark screw.

• Brand Name: OZARK SCREW
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11979661
• MDR Text Key: 257224481
• Report Number: 3004774118-2021-00174
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K172104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1