MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE 6.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6201-06550
Medical Device Problem Codes	Mechanical Problem (1384); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient received revision surgery for a mesa 2 polyaxial screw on the left side that no longer held the rod.The device has been explanted.
Event or Problem Description
It was reported that a patient received revision surgery for a mesa 2 polyaxial screw on the left side that no longer held the rod.The device has been explanted.
Additional Manufacturer Narrative
Visual inspection: the screw was positioned in the locked state upon receipt.Loss of anodization can also be observed.Functional inspection: the screw was able to be unlocked and locked as intended.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.According to the complainant, there was a potential short rod in the collet, not circular geometry because of rod cutting.It is possible that non-union or post-operative patient activities, coupled with short overhang length, contributed to the failure.According to the ifu, these internal fixation devices are load sharing devices which maintain alignment until healing occurs.If healing is delayed or does not occur, the implant could eventually break, bend, or loosen.Physical activity and load bearing have been implicated in premature loosening, bending or fracture of internal fixation devices in the absence of complete bone healing.As we were unable to confirm if fusion or trauma had occurred, we were unable to determine the root cause conclusively.

• Brand Name: MESA 2 DEFORMITY 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: 11008283
• Report Number: 3004774118-2020-00347
• Device Sequence Number: 4495740
• Product Code: NKB
• UDI-Device Identifier: 10888857164574
• UDI-Public: 10888857164574
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K143334
• 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
• Report Date (Section B): 06/21/2021

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: 6201-06550
• Device Catalogue Number: 6201-06550
• Device Lot Number: GPKN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 06/21/2021
• 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