MAUDE Adverse Event Report: K2M. INC MOJAVE EXPANDABLE INTERBODY SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 7012-2112407C-G3

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Death (1802); No Information (3190)

Event Date 11/29/2018

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) 2018 it was reported to k2m, inc.That a surgery took place in which an expandable interbody implant broke during insertion.It is unknown whether the clip or a portion of the component remains in the patient.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.It was reported during a surgery utilizing the everest pedicle screw system, the patient experienced a change in medical condition.The hardware application was stopped to attend to the medical condition.The hardware application was not completed.No adverse events involving hardware were observed.As reported by the surgeon, this was not a hardware related event.

Event Description

It was reported during a surgery utilizing the everest pedicle screw system, the patient experienced a change in medical condition.The hardware application was stopped to attend to the medical condition.The hardware application was not completed.No adverse events involving hardware were observed.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.It was reported that there is loose movement of the expanding knob in the medial/lateral directions.The sideways motion of the implant is not indicative of an adverse event.The locking screw was put into place and the implant is locked into place as intended.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That during surgery the expandable interbody broke intra-operatively.The implant was locked into place and retained inside the patient.

• Brand Name: MOJAVE EXPANDABLE INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8178294
• MDR Text Key: 130847594
• Report Number: 3004774118-2018-00184
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K171097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7012-2112407C-G3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2901-90042 LOT UNKNOWN; 2901-90043 LOT UNKNOWN; 2911-06545 LOT UNKNOWN
• Patient Outcome(s): Death