MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-05030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the polyaxial screw broke post operatively; patient underwent revision surgery.
Additional Manufacturer Narrative
Corrected data: dimensional, functional, and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.It was reported that a yukon oct polyaxial screw broke approximately three months postoperatively.The explanted hardware was not available for evaluation as it was retained by the hospital; however, the failure was confirmed through x-rays and photos supplied by the rep.Upon review, it was observed that the screw shank had fractured immediately distal to the screw head assembly.The yukon oct surgical technique was reviewed and the following relevant information was identified: after the pedicle screw pathway has been prepared and proper screw size has been determined, load the implant for screw insertion using a yukon screw inserter.When loading the yukon screws, grasp the implant by the screw shaft and give a slight rotation, while simultaneously applying a downward force to properly engage the screw.Once loaded, spin the knob located above the sleeve clockwise to lock the screw in place.The yukon screw inserter has a black sleeve for ease of identification.Once the screw has been loaded, insert it into the pilot hole until desired depth is reached.Disengage the screw inserter by turning the knob above the sleeve counter-clockwise.Repeat until all screws are placed.As the implant was not returned, the root cause could not be determined conclusively.It is possible the failure occurred in fatigue.Screws at the most caudal level of the construct are subjected to more stress.Repeated bending motions can compound cantilever forces at the proximal screw shank, resulting in a failure of this nature.X-rays also revealed that no adjacent screws were placed, which leaves the subject t1 screw with less stability.Device was not returned for evaluation.
Event or Problem Description
It was reported that the polyaxial screw broke post operatively; patient underwent revision surgery.

• Brand Name: POLYAXIAL SCREW; SIZE 5.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 8798310
• Report Number: 3004774118-2019-00068
• Device Sequence Number: 221388
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 7601-05030
• Device Lot Number: GGXT
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 10/25/2019
• 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