MAUDE Adverse Event Report: K2M INC. ALEUTIAN INTERBODY SYSTEMS; VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 603-20922C

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Information (3190)

Event Date 08/15/2017

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.

Event Description

On (b)(6) 2017 it was reported to k2m, inc.That a patient presented with a possible cage migration posteriorly.The patient reportedly had a possible cage migration approximately 2 months post-op.There are no plans to revise at this time.The patient is asymptomatic.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.No revision surgery has been scheduled at this time so parts are not available for detailed investigation, and a thorough investigation could not be completed as the lot number has not been identified/confirmed in this case.It was reported the surgeon has adjusted the sizing format he uses along with grafting techniques.Grafting or sizing could contribute to migration however no specific cause could be determined.Since the interbody remains in the patient, 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 patient presented with a possible cage migration posteriorly.The patient reportedly had a possible cage migration approximately 2 months post-op.The patient has not been revised and remains asymptomatic.

• Brand Name: ALEUTIAN INTERBODY SYSTEMS
• Type of Device: VERTEBRAL BODY REPLACEMENT 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: 6861639
• MDR Text Key: 86349907
• Report Number: 3004774118-2017-00121
• Device Sequence Number: 1
• Product Code: MQP
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2017

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: 603-20922C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 08/15/2017
• Supplement Dates FDA Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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