MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06550
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that a mesa polyaxial screw migrated post-operatively.Revision surgery was performed on (b)(6) 2020 to remove and replace the screw.
Additional Manufacturer Narrative
Device was returned.
Event or Problem Description
It was reported that a mesa polyaxial screw migrated post-operatively.'revision surgery was performed to remove and replace the screw.
Event or Problem Description
It was reported that a mesa polyaxial screw migrated post-operatively.'revision surgery was performed to remove and replace the screw.
Additional Manufacturer Narrative
Visual inspection: the screw head was separated from the shank and remained partially-locked onto the rod.No signs of fracture or deformation were found on the screw head.The shank was inspected and found to be in fair condition with moderate signs of wear.No fracture or significant damage was found on the shank.Based on the failure mode, it appears that a tensile/bending force managed to separate the shank and screw head.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.No root cause for the issue was able to be determined based on the available information.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X50 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9720043
• Report Number: 3004774118-2020-00016
• Device Sequence Number: 2401533
• Product Code: NKB
• UDI-Device Identifier: 10888857136212
• UDI-Public: 10888857136212
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2020

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: 801-06550
• Device Catalogue Number: 801-06550
• Device Lot Number: TBC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 03/16/2020; 06/22/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/10/2020; 07/21/2020
• 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
• Patient Age: 23 YR
• Patient Weight: 110