MAUDE Adverse Event Report: K2M INC. MESA® SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 801-06555

Device Problems Mechanical Jam (2983); Insufficient Information (3190)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 03/05/2019

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 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) 2019 it was reported to k2m, inc.That three screws were unable to be implanted as intended intra-operatively.A porton of the component remains in the patient.

Manufacturer Narrative

Manufacturing records were reviewed and no relevant manufacturing issues were discovered.The two removed mesa polyaxial screws were returned and inspected.Upon visual inspection, there was no damage to the screws nor any abnormalities.The inner and outer collet were intact.It is possible that the instrument used for partial locking was not functioning as intended and could have caused partial locking error in the 2 returned screws and the additional screw in l3.It is also possible that the rod placed on the mesa polyaxial screws was not fully reduced prior to locking.However, since the instruments used for locking and rod reduction were not available, the failure mode could not be replicated and a conclusive root cause cannot be established.

Event Description

Physician reported that they were unable to partial lock or final lock three screws intra-operatively.A portion of the component remains in the patient.

• Brand Name: MESA® SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8457557
• MDR Text Key: 140145190
• Report Number: 3004774118-2019-00032
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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: Health Professional
• Device Catalogue Number: 801-06555
• Device Lot Number: GYCP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1