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

Model Number F2911-05550

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 04/15/2020

Event Type  Injury  

Event 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.

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 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 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.

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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10051466
• MDR Text Key: 190761714
• Report Number: 3004774118-2020-00087
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857146013
• UDI-Public: 10888857146013
• Combination Product (y/n): N
• PMA/PMN Number: K151727
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F2911-05550
• Device Catalogue Number: F2911-05550
• Device Lot Number: KBAT-213004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 88