MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number UNK_SPE

Device Problems Failure to Osseointegrate (1863); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/05/2019

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

A cascadia cage was implanted during index surgery and instrumented with the cayman plate.The patient started to have returning symptoms of back pain and le dysesthesias.There is a potential for revision surgery.This record represents the plate.

Manufacturer Narrative

Corrections were mad to d3 & g1: updated from 'stryker spine-leesburg' to 'k2m, inc'.Visual, functional, material, and dimensional analysis were unable to be performed since the device was never returned for investigation.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Cascadia tl surgical technique was reviewed and the following relevant information was identified: the surgeon should adequately instruct the patient that postoperative care and the patient's ability and willingness to follow instructions are two of the most important aspects of successful healing.The surgeon should also inform the patient about potential postoperative adverse consequence as internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur the implant could eventually break, bend or loosen.Periodic x-rays for at least the first year postoperatively are recommended for close comparison with postoperative conditions to detect any evidence of changes in position, nonunion, loosening, and bending or cracking of components.With evidence of these conditions, patients should be closely observed, the possibilities of further deterioration evaluated, and the benefits of reduced activity and/or early revision considered.It is not clear if there was a traumatic event or another catalyst which triggered the adverse event.No evidence of a device malfunction was communicated and it is unclear what failure modes, if any, had occurred.As a result, no root cause for the adverse event could be determined based on the available information.

Event Description

A cascadia cage was implanted during index surgery and instrumented with the cayman plate.The patient started to have returning symptoms of back pain and le dysesthesias.There is a potential for revision surgery.This record represents the plate.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9158676
• MDR Text Key: 166769432
• Report Number: 3004774118-2019-00118
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• PMA/PMN Number: K190584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SPE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other