MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 7.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-07545
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During a planned revision surgery to perform additional compression on an existing construct, the surgeon noted that a mesa polyaxial screw was not secured to the rod.Surgery was successfully completed with no delay and no adverse consequences to the patient were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Post-operative patient activities may have introduced unanticipated loading to the construct, overloading the capture strength of the screw at l5.There is also a possibility that the subject screw was never locked during the index surgery.However, as the device remains implanted and unavailable for evaluation, the root cause could not be determined conclusively.H3 other text : device remains implanted.
Event or Problem Description
During a planned revision surgery to perform additional compression on an existing construct, the surgeon noted that a mesa polyaxial screw was not secured to the rod.The device remains implanted.Surgery was successfully completed with no delay and no adverse consequences to the patient were reported.

• Brand Name: POLYAXIAL SCREW; SIZE 7.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10125054
• Report Number: 3004774118-2020-00111
• Device Sequence Number: 14216438
• Product Code: NKB
• UDI-Device Identifier: 10888857136830
• UDI-Public: 10888857136830
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 801-07545
• Device Catalogue Number: 801-07545
• Device Lot Number: HNKG
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1