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

Catalog Number 2013-21336L10

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.Device evaluated by mfr: user disposed.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a surgery took place in which the third screw would not lock into a cage and the cage was left implanted with two screws.Surgery took place (b)(6) 2017.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.A review of all applicable material, inspection, manufacturing, and distribution records according to the description of the product(s) used was conducted.All records revealed that all product(s) lots were manufactured within specifications and distributed in accordance with all operating procedures.It was reported that the patient had poor bone quality and that the surgeon was not concerned about the integrity of the overall construct.Since the implants remain in the patient and the screw was disposed, no examination could be completed and therefore a definitive root cause could not be determined.(related to 3004774118-2017-00076 and 3004774118-2017-00058).User disposed/in situ.

Event Description

On 04.03.2017 it was reported to k2m, inc.That a surgery took place in which the third screw would not lock into a cage and the cage was left implanted with two screws.Surgery took place (b)(6) 2017.

• 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 ; 5719195195
• MDR Report Key: 6539752
• MDR Text Key: 74262236
• Report Number: 3004774118-2017-00052
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2017

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: 2013-21336L10
• Device Lot Number: ENBK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 05/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2016
• 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