MAUDE Adverse Event Report: K2M INC. EVEREST SPINAL SYSTEM; SPINAL FIXATION SYSTEM

Catalog Number 2901-10001

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Information (3190)

Event Date 09/06/2017

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery took place in which polyaxial screws were removed.Revision surgery took place on (b)(6) 2017.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.Investigation revealed that the patient was treated for plasmacytoma and fusion was not an intended treatment.Review of the bottom surface of the set screws indicated a windshield wiper pattern on the rod interface surface suggesting full rod contact was achieved.Linear marks across the screw head inner surface suggest the rods made full contact within the screw head.No abnormal marks were observed on either rod.The absence of fusion intent and/or interbody support could contribute to eventual hardware failure.However, a specific cause for this event could not be confirmed.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery took place due to a rod slip within the screw head.Revision surgery took place on (b)(6) 2017.Further investigation indicated that set screws were also compromised and removed from the patient along with the rod and polyaxial screw.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: SPINAL FIXATION 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: sandra gilbert ; 600 hope parkway se; leesburg, VA 20175 ; 5719192195
• MDR Report Key: 6895291
• MDR Text Key: 87513931
• Report Number: 3004774118-2017-00135
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 2901-10001
• Device Lot Number: EWTL,FAYC,ETAL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 69