MAUDE Adverse Event Report: K2M, INC. K2M NAVIGATION INSTRUMENTS

Catalog Number 2901-N90006

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product was returned for evaluation but evaluation is still in progress.Upon completion of evaluation of the subject part, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a surgery took place in which a pedicle screw breached the lateral wall of the pedicle.As a result, the surgeon extended the construct which resulted in a significant delay in the surgery.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.No correlation could be determined between the inserter and the right t4 pedicle screw breaching the lateral wall of the pedicle.It is possible that the screw did not follow the same trajectory of the probe that was used to prepare the pedicle.Further investigation revealed that the surgical delay was due to adjustment of the o arm to get right image and because of the blood clot that interfered with the navigation system and also repositioning of reference frame from o arm which was blocking the screw driver.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a surgery took place in which a pedicle screw breached the lateral wall of the pedicle.As a result, the surgeon extended the construct which resulted in a delay in the surgery.Surgery took place (b)(6) 2017.

• Brand Name: K2M NAVIGATION INSTRUMENTS
• Type of Device: NAVIGATION INSTRUMENT
• 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: 7039507
• MDR Text Key: 93205281
• Report Number: 3004774118-2017-00196
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 10/31/2017

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: 2901-N90006
• Device Lot Number: DUDRNB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 10/31/2017
• Supplement Dates FDA Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1