MAUDE Adverse Event Report: STRYKER-SPINE OZARK¿ CERVICAL PLATE SYSTEM; APPLIANCE FIXATION SPINAL INTERVERTEBRAL BODY

Catalog Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 12/19/2018

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2019 it was reported to k2m, inc.That a cervical plate backed-out, loosened or disengaged approximately 1-3 months post-operatively.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The device remains in the patient and was not available for evaluation.The subject screw was reportedly placed at the most caudal level of a three-level ozark view plate.Post-operative migration was unable to be confirmed, and there were no plans to revise the patient at the time of investigation.It was also reported that subject cover appeared to be dislodged from the plate.

Event Description

On 02.14.2019 it was reported to k2m, inc.That a screw backed-out, loosened or disengaged post-operatively.

• Brand Name: OZARK¿ CERVICAL PLATE SYSTEM
• Type of Device: APPLIANCE FIXATION SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER-SPINE; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): STRYKER-SPINE; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 8400541
• MDR Text Key: 138141268
• Report Number: 3004774118-2019-00023
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172104
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2019

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 02/14/2019
• Supplement Dates FDA Received: 09/18/2019
• 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