MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 801-05540

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 04/27/2020

Event Type  Injury  

Event Description

It was reported that 3 distal mesa polyaxial screws, on the left side, migrated post-operatively.The patient underwent initial surgery for a type c spinal cord injury of l1-l2 and spine instability.Revision surgery has occurred.This report represents the first of three screws.

Event Description

It was reported that 3 distal mesa polyaxial screws, on the left side, migrated post-operatively.The patient underwent initial surgery for a type c spinal cord injury of l1-l2 and spine instability.Revision surgery has occurred.This report represents the first of three screws.

Manufacturer Narrative

Functional, dimensional, and material analysis could not be performed as the device was not available.However, x-rays were reviewed and it was observed that three screws implanted at the distal end of the construct had pulled out of the bone.The subject screws were still engaged to the rod.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.As the screws were not available for evaluation, the root cause could not be determined conclusively.Non-union may have contributed to the failure.Based on the radiological image, it could not be determined if fusion was achieved.Incidence of pseudoarthrosis could allow for dynamic motion within the construct, causing the implants to loosen from the bone.Device not returned.

• Brand Name: POLYAXIAL SCREW; SIZE 5.5X40 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10121316
• MDR Text Key: 194116125
• Report Number: 3004774118-2020-00106
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857135574
• UDI-Public: 10888857135574
• 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: 10/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 801-05540
• Device Catalogue Number: 801-05540
• Device Lot Number: GYBK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/08/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention