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

Catalog Number E5112-06545

Device Problem Unintended Movement (3026)

Patient Problem Death (1802)

Event Date 06/19/2018

Event Type  Death  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been 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) 2018 it was reported to k2m, inc.That a the patient had a significant change in medical condition intra-operatively while the surgeon was using a k2m device.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.Based on the report from the distributor, a mazor robotics system was used to implant an everest xt screw.The part is not available for physical evaluation.It was determined that the incident was not related to a malfunction or failure of any k2m device.The manufacturing lot number could not be confirmed.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That a the patient had a significant change in medical condition intra-operatively while the surgeon was using a k2m device.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL 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: talisa creavalle ; 600 hope parkway se; leesburg, VA 20175 ; 5719192213
• MDR Report Key: 7643233
• MDR Text Key: 112512143
• Report Number: 3004774118-2018-00097
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: E5112-06545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2018
• 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
• Patient Outcome(s): Death
• Patient Age: 62 YR