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

Model Number	801-05540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/27/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 third of three screws.
Event or Problem 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 third of three screws.
Additional 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.H3 other text : device not returned.

• Brand Name: POLYAXIAL SCREW; SIZE 5.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10121299
• Report Number: 3004774118-2020-00108
• Device Sequence Number: 17011226
• Product Code: NKB
• UDI-Device Identifier: 10888857135574
• UDI-Public: 10888857135574
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 801-05540
• Device Catalogue Number: 801-05540
• Device Lot Number: GYBK
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention