MAUDE Adverse Event Report: K2M INC. ALEUTIAN IBF SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number 603-21028C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 09/28/2017

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 11.27.2017 it was reported to k2m, inc.That a revision surgery took place in which a migrated interbody was removed.Revision surgery took place (b)(6) 2017.(related to 3004774118-2017-00218).

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 theinterbody was retained by the hospital, no physical, chemical evaluation could be performed, and the root cause of the reported issue could not be ascertained.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a revision surgery took place in which a migrated interbody was removed.Revision surgery took place (b)(6) 2017.(related to 3004774118-2017-00218).

• Brand Name: ALEUTIAN IBF 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: 7149253
• MDR Text Key: 95867091
• Report Number: 3004774118-2017-00205
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110843
• 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: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 603-21028C
• Device Lot Number: FRXF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• 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
• Treatment: 101-10001 LOT FPMC
• Patient Outcome(s): Required Intervention