MAUDE Adverse Event Report: K2M. INC OZARK CERVICAL PLATE; SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS

Catalog Number 8801-42F40G

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 10/02/2018

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 that the covers on the plate disassembled approximately 4-6 months post-operatively.Revision of patient is not yet scheduled.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That the covers on the plate disassembled approximately 4 to 6 months post-operatively.Revision of patient is not yet scheduled.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.X-ray images confirmed the migration and breakage of the plate cover.The part was not available for inspection; therefore, we could not conclude the precise circumstances of this failure.

• Brand Name: OZARK CERVICAL PLATE
• Type of Device: SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8023129
• MDR Text Key: 125606965
• Report Number: 3004774118-2018-00158
• 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: other
• Type of Report: Initial,Followup
• Report Date: 10/02/2018

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 Catalogue Number: 8801-42F40G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 10/02/2018
• Supplement Dates FDA Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1