MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 801-05545

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

Patient Problem Injury (2348)

Event Date 10/29/2019

Event Type  Injury  

Manufacturer Narrative

Device remains implanted in patient.

Event Description

It was reported that the patient underwent revision surgery to reposition a mesa polyaxial screw implanted in l5.The screw was reported to be directed "a bit towards the vertebral disc".There is no product issue associated with the screw.The screw was re-positioned and remains implanted.Re-implantation of the screw is a contraindication of use.

Manufacturer Narrative

The mesa deformity surgical technique was reviewed and the following relevant information was identified: surgical implants must never be reused.An explanted metal implant should never be reimplanted.Even though the device appears undamaged, it may have small imperfections and internal stress patterns which may lead to early breakage.No issue related to the reported event was found with this product.

Event Description

It was reported that the patient underwent revision surgery to reposition a mesa polyaxial screw implanted in l5.The screw was reported to be directed "a bit towards the vertebral disc".There is no product issue associated with the screw.The screw was re-positioned and remains implanted.Re-implantation of the screw is a contraindication of use.

• Brand Name: POLYAXIAL SCREW; SIZE 5.5X45 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10121172
• MDR Text Key: 194113750
• Report Number: 3004774118-2020-00105
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K141873
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 801-05545
• Device Lot Number: JERN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 09/17/2020
• Supplement Dates FDA Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention