MAUDE Adverse Event Report: K2M. INC CHESAPEAKE® STABILIZATION SYSTEM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 2013-21536L20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 09/17/2018

Event Type  Injury  

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 patient developed an infection post-operatively.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject implant and associated surgical equipment was not available for evaluation.A review of reported sterilization specifications did not reveal any discrepancies.A correlation between the interbody and the infection could not be made.

Event Description

On (b)(6) 2018 it was reported to k2m, inc that a patient developed an infection post-operatively.

• Brand Name: CHESAPEAKE® STABILIZATION SYSTEM
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va 20175
• MDR Report Key: 8163872
• MDR Text Key: 130317801
• Report Number: 3004774118-2018-00183
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: K145487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2013-21536L20
• Device Lot Number: FKLP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other