MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 6.5X35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	101-06535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status of the device is currently unknown.
Event or Problem Description
It was reported that two denali polyaxial screws fractured post-operatively.Revision surgery was performed.This report represents the 1st of the 2 screws.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned and x-rays were not provided.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.The denali surgical technique was reviewed and the following was identified: 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.Load produced by load bearing and activity levels will impact the longevity of the implant.Metallic implants can loosen, fracture, corrode, migrate, cause pain, or stress shield bone even after a bone has healed.If an implant remains implanted after complete healing, it can actually increase the risk of re fracture in an active individual.It is possible that these fractures could have occurred due to fatigue or instantaneous loading.However, a conclusive root cause could not be established based on available information.
Event or Problem Description
It was reported that two denali polyaxial screws fractured post-operatively.Revision surgery was performed.This report represents the 1st of the 2 screws.

• Brand Name: POLYAXIAL SCREW; SIZE 6.5X35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9638177
• Report Number: 3004774118-2020-00014
• Device Sequence Number: 319577
• Product Code: NKB
• UDI-Device Identifier: 10888857002715
• UDI-Public: 10888857002715
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K141873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2020

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: 101-06535
• Device Catalogue Number: 101-06535
• Device Lot Number: EVUE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/15/2020
• 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