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

Catalog Number 801-36545

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 08/31/2018

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 broke at the shaft approximately 24 months post-operatively.A piece of the shaft portion remains in the patient.Revision surgery took place (b)(6) 2018.

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.Upon review of the first screw (dytv), it was observed that the screw had sheared at the shaft.The outer collet was separated from the inner collet, which is consistent with the effects of damage upon removal.

Event Description

On (b)(6) 2018 it was reported to k2m, inc.That two screws broke at the shaft approximately 24 months post-operatively.A piece of the shaft remains implanted in the patient.Revision surgery took place on (b)(6) 2018.

• Brand Name: MESA SPINAL SYSTEMS
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): K2M. INC; 600 hope parkway se; leesburg, va VA 20175
• MDR Report Key: 7906178
• MDR Text Key: 121609915
• Report Number: 3004774118-2018-00145
• 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: 08/31/2018

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: 801-36545
• Device Lot Number: DYTV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 08/31/2018
• Supplement Dates FDA Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 801-36545 LOT CVGV
• Patient Outcome(s): Required Intervention