MAUDE Adverse Event Report: K2M INC. EVEREST SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 2911-06545

Device Problems Break (1069); Fracture (1260)

Patient Problems Pain (1994); No Information (3190)

Event Date 02/27/2019

Event Type  Injury  

Manufacturer Narrative

A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product will not be returned for evaluation.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 six polyaxial screws broke at the shaft approximately 1-3 months post- operatively.A portion of the broken shaft remains in the patient.

Manufacturer Narrative

Manufacturing records were not able to be reviewed as lot numbers were not available.It is possible that the sporadic flexion motion could have created excessive force on the construct, causing the screws at the caudal most level to fracture at the shaft.Additional patient activities could have caused the construct to weaken prior to the event.However, since the implants were not available for investigation, a root cause cannot be determined conclusively.

Event Description

Physician reported that six polyaxial screws broke at the shaft approximately 1-3 months postoperatively.A portion of the broken shaft remains in the patient.Patient reported pain.Revision surgery has not been scheduled.

• Brand Name: EVEREST SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8734122
• MDR Text Key: 149189604
• Report Number: 3004774118-2019-00064
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K133944
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2911-06545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention