MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; UNKNOWN DEVICE

Catalog Number UNK_SPE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bone Fracture(s) (1870); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is unknown.

Event Description

This record captures a review of the literature article "clinical outcomes after minimally invasive trans-psoas lateral lumbar interbody fusion for the treatment of adult degenerative scoliosis: four years¿ multicenter study".The objective of this study was to evaluate the clinical outcomes of adults with degenerative lumbar scoliosis who were treated with minimally invasive llif.Thirty-two consecutive patients with adult degenerative scoliosis treated by a single surgeon at two spine centers were followed up for an average of 13.2 months.The patients were either implanted with aleutian or cascadia cages.One patient experienced vertebral body fracture and subsequent loss of emg signals, whereas then the procedure was abandoned.

Manufacturer Narrative

The article 'clinical outcomes after minimally invasive trans-psoas lateral lumbar interbody fusion for the treatment of adult degenerative scoliosis: four years¿ multicenter study' in the indian journal of neurosurgery, volume 9 (225-229) 2020 was reviewed.Visual, functional, dimensional, and material analysis inspections could not be performed as the devices were not available.Device and complaint history records for the devices could not be reviewed as a valid lot number was not available and could not be obtained.It was reported in the study that one patient experienced vertebral body fracture with loss of electromyography (emg) signals intra-operatively.The procedure was abandoned, and the patient subsequently underwent lateral fixation without interbody fusion.There were no allegations of device failure.Additional information regarding this event is not known and could not be obtained via the author; therefore, a root cause could not be determined conclusively.

Event Description

This record captures a review of the literature article "clinical outcomes after minimally invasive trans-psoas lateral lumbar interbody fusion for the treatment of adult degenerative scoliosis: four years¿ multicenter study".The objective of this study was to evaluate the clinical outcomes of adults with degenerative lumbar scoliosis who were treated with minimally invasive llif.Thirty-two consecutive patients with adult degenerative scoliosis treated by a single surgeon at two spine centers were followed up for an average of 13.2 months.The patients were either implanted with aleutian or cascadia cages.One patient experienced vertebral body fracture and subsequent loss of emg signals, whereas then the procedure was abandoned.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: UNKNOWN DEVICE
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12411072
• MDR Text Key: 278399384
• Report Number: 3004774118-2021-00265
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other