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

Catalog Number 2901-10001

Device Problems Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 04/08/2019

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) 2019 it was reported to k2m, inc.That a surgery took place in which a set screw did not perform according to specifications.The patient was revised on (b)(6) 2019.

Manufacturer Narrative

The device was not returned for evaluation.Manufacturing records could not be reviewed as the lot number was unavailable.It is possible that the rod on the left-hand side was not fully reduced during implantation, resulting in insufficient capture during final tightening.This could have created unanticipated motion in the construct which could have caused the set screws to loosen.It is also possible that the set screw was not torqued sufficiently during final tightening in initial surgery.However, since the device was unavailable for inspection and evaluation, a root cause could not be determined conclusively.

Event Description

The patient initially underwent a l5/s1 plif during which only one cage was implanted (on the left side) due to constrained disk space.It was reported that patient experienced leg pain post-operatively.During the revision surgery, it was found that the set screws on the left side were loosened.(related to 3004774118-2019-00046).

• 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: 8567589
• MDR Text Key: 143665509
• Report Number: 3004774118-2019-00045
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2901-10001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 1001-E5545 LOT UNKNOWN.; 1001-E5545 LOT UNKNOWN.; F2911-06540 LOT UNKNOWN.; F2911-06540 LOT UNKNOWN.; F2911-07540 LOT UNKNOWN.; F2911-07540 LOT UNKNOWN.
• Patient Outcome(s): Required Intervention