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

Catalog Number	2911-06540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	10/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Remains implanted.
Event or Problem Description
A physician reported that a patient was experiencing pain ten weeks post-operatively.Follow-up revealed a broken everest polyaxial screw.Revision surgery is planned but has not been scheduled.
Additional Manufacturer Narrative
Correction: no selection has been updated to "required intervention to prevent permanent impairment/damage (devices)." visual inspection: photos of the device were reviewed.It was observed that the screw shank had fractured at the s1 level.Dimensional, functional, and material analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed because the device associated with this event was not returned.Therefore, a valid lot code was not provided and could not be obtained.According to the product insert, internal fixation devices are load sharing devices which maintain alignment until healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.If a nonunion develops or if the implants loosen, bend or break, the device(s) should be revised or removed immediately before serious injury occurs.Fusion at the subject level could not be confirmed, therefore, it is possible the failure occurred in fatigue.
Event or Problem Description
A physician reported that a patient was experiencing pain ten weeks post-operatively.Follow-up revealed a broken everest polyaxial screw.Revision surgery is planned but has not been scheduled.

• 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: 9362712
• Report Number: 3004774118-2019-00147
• Device Sequence Number: 2626605
• Product Code: NKB
• UDI-Device Identifier: 10888857042315
• UDI-Public: 10888857042315
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133944
• 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): 12/27/2019

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 Catalogue Number: 2911-06540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/27/2019
• 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