MAUDE Adverse Event Report: K2M INC. CHESAPEAKE STABILIZATION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Catalog Number 2001-15525D

Device Problems Insufficient Information (3190); Migration (4003)

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

Event Date 09/21/2018

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) 2019 it was reported to k2m, inc that a self starting screw backed out, loosened, disengaged approximately 4-6 months post-operatively.Revision surgery has not yet been scheduled.

Event Description

After reviewing patient's 6 month follow up x-ray, physician reported that a self starting screw backed out, loosened, disengaged post-operatively.Patient is experiencing pain and revision surgery will be scheduled.

Manufacturer Narrative

Manufacturing records for the chesapeake anterior lumbar implant were reviewed and no relevant manufacturing issues were found.Manufacturing records for the chesapeake self-starting screw could not be reviewed as lot number was unavailable.In the event that a chesapeake self-starting screw backs out of a chesapeake anterior lumbar implant, it is possible that the screw was over torqued or threaded through the tifix insert.It was also reported that the patient experienced pseudarthrosis, which could have caused the screw to back out as well.Internal fixation devices are load sharing devices that maintain alignment until healing occurs.If healing is delayed or does not occur, then the implant can eventually break, bend, or loosen.Loads produced by load bearing and activity levels will impact the longevity of implant.As fusion was prevented by pseudarthrosis, this could have created excessive force on the caudal most level screw, causing it to back out.However, as the implants were unavailable for inspection, a root cause cannot be determined conclusively.

• Brand Name: CHESAPEAKE STABILIZATION SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): K2M INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8512602
• MDR Text Key: 141915337
• Report Number: 3004774118-2019-00036
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: K142487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2001-15525D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Weight: 81