MAUDE Adverse Event Report: K2M, INC. UNKNOWN MESA DEVICE

Catalog Number UNK_SPE

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2021

Event Type  malfunction  

Manufacturer Narrative

Status and location of the device is currently unknown.

Event Description

It was reported that 'surgery for mesa removal' occurred.No further information is available at this time.

Manufacturer Narrative

Corrected data: b.5.And h.6.Method code have been updated to reflect that an event did not occur with a stryker device.This was a scheduled revision and the patient had fused.This record will no longer be reportable.

Event Description

It was reported that 'surgery for mesa removal' occurred.No further information is available at this time.Additional information received has clarified that an event did not occur with a stryker device.This was a scheduled revision and the patient had fused.

• Brand Name: UNKNOWN MESA DEVICE
• Type of Device: UNKNOWN MESA 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12980283
• MDR Text Key: 282097044
• Report Number: 3004774118-2021-00389
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/12/2021
• 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
• Patient Outcome(s): Required Intervention