MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 3.5X26 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-03526
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Return status of the device is unknown.
Event or Problem Description
Stryker representative reported that a yukon oct spinal system polyaxial screw; size ø3.5x26 mm fractured 1-3 months post-operatively.Revision surgery has occurred.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, photos and x-ray images were provided.Upon review of the lateral x-ray image, it can be seen that the yukon polyaxial screw implanted in the caudal most level of the construct (level c2) has fractured.Explanted screw images show that the fracture line is located on the main body of the shaft, proximal to the tulip of the screw.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.Per surgical technique: patient selection and compliance is extremely important.Spinal implant surgery on patients with conditions listed under the contradictions may not be candidates for this procedure.The patient must be made aware of the limitations of the implant and that physical activity and load bearing have been implicated in premature loosening, bending, or fracture of the internal fixation devices.The patient should understand that a metalic implant is not as strong as a normal, healthy bone and will fracture under normal load bearing in absence of complete bone healing.Cutting, bending, or scratching of the surface of the metal components can significantly reduce the strength and fatigue resistance of the implant system and should be avoided where possible.These, in turn may cause cracks and/or internal stresses that are not obvious to the eye and may lead to fracture of the components.Especially avoid sharp or reverse bends and notches." as the device was not available for inspection, the fracture surface of the screw could not be analyzed to determine the possible root cause of the event.H3 other text : device has been discarded.
Event or Problem Description
Stryker representative reported that a yukon oct spinal system polyaxial screw; size ø3.5x26 mm fractured 1-3 months post-operatively.Revision surgery has occurred.

• Brand Name: POLYAXIAL SCREW; SIZE 3.5X26 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9770929
• Report Number: 3004774118-2020-00022
• Device Sequence Number: 19424760
• Product Code: NKG
• UDI-Device Identifier: 10888857349377
• UDI-Public: 10888857349377
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 7601-03526
• Device Catalogue Number: 7601-03526
• Device Lot Number: JARX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 05/27/2020
• 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: Hospitalization