MAUDE Adverse Event Report: K2M, INC., CHESAPEAKE STABALIZATION SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 3601-13516

Device Problems Device Operational Issue (2914); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

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) 2017 it was reported to k2m, inc.That during surgery a cage broke while driving a screw.The screw and the broken cage was removed.A new cage was placed instead.(related to 3004774118-2017-00112 and 3004774118-2017-00125).

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The product was not returned to manufacturer for evaluation, and a thorough investigation could not be completed as the lot number has not been identified in this case.Since the device was disposed by the hospital, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.Interbody was reportedly damaged by a self-tapping screw during final tightening.During final tightening there was insufficient resistance to trigger the limit of the handle.It is possible that the self-tapping screw was over-torqued during provisional placement, but utilization of this technique and associated instrumentation could not be confirmed.It is also possible that fracturing was initiated during impaction, while the spring awl was being engaged, or during off-axis hand tightening of the medial screw after the drill guide was removed from the implant.(related to 3004774118-2017-00112 and 3004774118-2017-00125).

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That during surgery a cage broke while driving a screw.The screw and the broken cage was removed.A new cage was placed instead.(related to 3004774118-2017-00112 and 3004774118-2017-00125).

• Brand Name: CHESAPEAKE STABALIZATION SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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 ; 5719195195
• MDR Report Key: 6814724
• MDR Text Key: 83695458
• Report Number: 3004774118-2017-00124
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/24/2017

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: Physician
• Device Catalogue Number: 3601-13516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 09/27/2017
• 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