MAUDE Adverse Event Report: K2M, INC. FENESTRATED, POLYAXIAL SCREW; SIZE 5.5X50 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	F2911-05550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an everest fenestrated polyaxial screw fractured post-operatively.The patient did not fuse and revision surgery was performed to remove the fractured screw.
Additional Manufacturer Narrative
Functional, dimensional, and material analysis could not be performed as the device was not returned.However, x-rays were provided by the rep.Upon review, it was observed that a screw had fractured at the most caudal level of a construct.The fracture occurs approximately one centimeter below the proximal screw housing.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.It is possible non-union contributed to the failure, as the patient did not fuse.However, as the device was not available for evaluation, the root cause could not be determined conclusively.H3 other text : status and location of the device is unknown.
Event or Problem Description
It was reported that an everest fenestrated polyaxial screw fractured post-operatively.The patient did not fuse and revision surgery was performed to remove the fractured screw.
Event or Problem Description
It was reported that an everest fenestrated polyaxial screw fractured post-operatively.The patient did not fuse and revision surgery was performed to remove the fractured screw.
Additional Manufacturer Narrative
Section d.4 was updated to reflect lot/serial number received.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.

• Brand Name: FENESTRATED, POLYAXIAL SCREW; SIZE 5.5X50 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10051466
• Report Number: 3004774118-2020-00087
• Device Sequence Number: 11488068
• Product Code: NKB
• UDI-Device Identifier: 10888857146013
• UDI-Public: 10888857146013
• Combination Product (Y/N): N
• PMA/510(K) Number: K151727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2020

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: F2911-05550
• Device Catalogue Number: F2911-05550
• Device Lot Number: KBAT-213004
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 08/17/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 07/28/2020; 09/11/2020
• 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: 72 YR
• Patient Weight: 88