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

Model Number UNKNOWN

Device Problems Material Deformation (2976); No Apparent Adverse Event (3189)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that 2 ozark screws and the locking mechanism of an ozark plate broke 6 months post-operatively.Revision surgery has not been scheduled nor performed at this time.This report captures the plate.

Manufacturer Narrative

Correction: b5 has been updated with additional information as this report is a duplicate of manufacturer report # 3004774118-2021-00148.

Event Description

Update: this report has been identified to be a duplicate of manufacturer report # 3004774118-2021-00148.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 11942766
• MDR Text Key: 254545379
• Report Number: 3004774118-2021-00165
• 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: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNK_SPN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1