MAUDE Adverse Event Report: K2M, INC. MESAMINI 90 SCREW; SIZE 4.0X32 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 1101-04032F

Device Problems Fracture (1260); Material Separation (1562)

Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2020

Event Type  Injury  

Manufacturer Narrative

Status and location of the device is unknown.

Event Description

A physician reported that two screws, "fractured from the head," post-operatively.The patient has been revised.This report represents the second of two screws.

Manufacturer Narrative

Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.No further investigation can be performed due to insufficient information provided.If more information is received and/or devices are returned for evaluation this investigation will be reopened and updated.

Event Description

A physician reported that two screws, "fractured from the head," post-operatively.The patient has been revised.This report represents the second of two screws.

Manufacturer Narrative

The following fields have been corrected following receipt of additional information: a1, b3, b5, d2, d4, d6, g4, h6.

Event Description

A physician reported that a two screws fractured "at the level of the thread between the first and second with erosion of the pedicular traject." the patient has undergone revision surgery.This report represents the second of two screws.

Event Description

A physician reported that a two screws fractured "at the level of the thread between the first and second with erosion of the pedicular traject." the patient has undergone revision surgery.This report represents the second of two screws.

Manufacturer Narrative

The device was not returned so an evaluation could not be performed.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Limited information regarding the event was made available to stryker.Multiple attempts were made to obtain additional information, but no response was received.A root cause cannot be established.If additional information is received or the device is returned for evaluation, the investigation will be reopened and updated.

• Brand Name: MESAMINI 90 SCREW; SIZE 4.0X32 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10497475
• MDR Text Key: 205875199
• Report Number: 3004774118-2020-00199
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K153370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1101-04032F
• Device Lot Number: PDH-AVNL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 14