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

Catalog Number 2001-15525D

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 12/14/2017

Event Type  malfunction  

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 was completed as the lot number has been identified/confirmed in this case.Since the metal shards were retained by the hospital, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.The shard shape and color appeared to be that of the screw ti-fix thread.Stripping of the ti-fix feature could contribute to material deformation or separation.The cause of the ti-fix thread stripping could not be confirmed for this event.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That during a surgery, it was observed after insertion of the screw a metal shard came off the screw or the locking mechanism.Metal shards were retrieved successfully.Related to (b)(4).

• Brand Name: CHESAPEAKE STABILIZATION 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 ; 5719192195
• MDR Report Key: 7402120
• MDR Text Key: 105161958
• Report Number: 3004774118-2018-00038
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 2001-15525D
• Device Lot Number: FXXJ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2017
• 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 Age: 57 YR