MAUDE Adverse Event Report: K2M INC. MESA® SPINAL SYSTEM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 801-07545

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Injury (2348); No Information (3190)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That two screws disengaged approximately 1 week post-operatively.Patient was revised (b)() 2018 (related to 3004774118-2018-00191).

Manufacturer Narrative

The construct, spanning t6 to l5, included a rail on the left side, a rod on the right, and mesa screws throughout.The subject screws were located at l4 and l5 on the right side.The implant was returned, visually and microscopically inspected.The polyaxial screw presented significant deformation at the head assembly, which may have been introduced during removal.It could not be determined if the screw was fully locked in the index surgery.Manufacturing and inspection records of the subject lot was reviewed, and no discrepancies were discovered.Root cause could not be determined.Correction: lot number was corrected from bkexa040b to bkexa.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That two screws disengaged approximately 1 week post-operatively.(related to 3004774118-2018-00191).

• Brand Name: MESA® SPINAL SYSTEM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8181866
• MDR Text Key: 130977606
• Report Number: 3004774118-2018-00192
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801-07545
• Device Lot Number: BKEXA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 12/03/2018
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 801-06545 LOT DYRF02D
• Patient Outcome(s): Required Intervention