MAUDE Adverse Event Report: K2M, INC. CHESAPEAKE® STABILIZATION SYSTEM ALIF; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 2001-15525D

Device Problems Metal Shedding Debris (1804); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

Surgeon noticed metal pieces in the sterile field as they advanced the screw.The pieces were blue in color, the same color as the screw.It was then determined that the metal pieces were pieces of screw thread.

• Brand Name: CHESAPEAKE® STABILIZATION SYSTEM ALIF
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): K2M, INC.; 600 hope parkway; leesburg VA 20175
• MDR Report Key: 7320058
• MDR Text Key: 101773956
• Report Number: 7320058
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 2001-15525D
• Device Catalogue Number: 2001-15525D
• Device Lot Number: FXXJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR