MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	801-06540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that two mesa polyaxial screws fractured post-operatively.The patient will not have revision surgery despite having pain.This report represents the second of the two screws.
Additional Manufacturer Narrative
Visual, functional, material, and dimensional analysis could not be performed as the device was not returned because it remains in the patient.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.Per the mesa surgical technique, 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,.Non-union may have contributed to the failure.However, as the devices were not available for evaluation, the root cause could not be determined conclusively.
Event or Problem Description
It was reported that two mesa polyaxial screws fractured post-operatively.The patient presented with lower back pain.Revision surgery will not be performed.This report represents the second of the two screws.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9962935
• Report Number: 3004774118-2020-00071
• Device Sequence Number: 2740678
• Product Code: NKB
• UDI-Device Identifier: 10888857136113
• UDI-Public: 10888857136113
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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: 801-06540
• Device Catalogue Number: 801-06540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 04/15/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1