MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; UNKNOWN CAGE

Catalog Number UNK_SPE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Return status is unknown.

Event Description

Through a clinical study, it was reported that three (3) patients experienced an infection post-operatively.Implant dates provided as '(b)(6) 2018 to (b)(6) 2020'.Explant dates have not been provided.Device information provided as 'capri® cervical 3d expandable corpectomy cage system'.No further details have been provided.This report will capture the second of three patients.

Event Description

Through a clinical study, it was reported that three (3) patients experienced an infection post-operatively.Implant dates provided as (b)(6) 2018 to (b)(6) 2020'.Explant dates have not been provided.Device information provided as 'capri® cervical 3d expandable corpectomy cage system'.No further details have been provided.This report will capture the second of three patients.

Manufacturer Narrative

Additional information provided by the operating physician indicates the device did not cause or contribute to the reported events.The events were a result of pre-existing patient conditions.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: UNKNOWN CAGE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10959141
• MDR Text Key: 219981602
• Report Number: 3004774118-2020-00329
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 02/27/2021
• Supplement Dates FDA Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other