MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number UNK_SPE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problem Injury (2348)

Event Date 02/12/2020

Event Type  Injury  

Manufacturer Narrative

Return status of the device is unknown.

Event Description

Stryker representative reported that the placement of an unknown illiac screw was not 'optimal' post-operatively.Revision surgery has occurred.

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.Per surgical technique: operative.4.The placement of screws should be checked radiographically prior to assembly of the rod construct.5.Care should be taken when positioning the implants to avoid neurological damage.It was determined that there is no product problem with the device.The surgeon decided to remove the screw because he was not satisfied with the trajectory.

Event Description

Stryker representative reported that the placement of an unknown illiac screw was not 'optimal' post-operatively.Revision surgery has occurred.

• Brand Name: UNKNOWN_K2M_PRODUCT
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9832855
• MDR Text Key: 183769010
• Report Number: 3004774118-2020-00029
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: K132361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2020
• 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: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other