MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW; SIZE 3.5X14 MM; POSTERIOR CERVICAL SCREW SYSTEM

Catalog Number	7601-03514
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Status and location of the device are currently unknown.
Event or Problem Description
A yukon screw inserter "stuck" to the screw while inserting at the right c3, causing the surgeon to apply additional force.This force broke through the lateral mass which made it essential to extend the construct up to the right c2 resulting in a 10 minute surgical delay.This record captures the polyaxial screw.
Additional Manufacturer Narrative
Correction: updated summary to concomitant product.Updated stryker spine-leesburg to k2m, inc.No issue related to the reported event was found with the yukon oct polyaxial screw; therefore, it is a concomitant product.The issue lies with the yukon oct screw inserter.An investigation was performed on the contributing product (mrn # 3004774118-2019-00120).
Event or Problem Description
A yukon screw inserter "stuck" to the screw while inserting at the right c3, causing the surgeon to apply additional force.This force broke through the lateral mass which made it essential to extend the construct up to the right c2 resulting in a 10 minute surgical delay.This record captures the polyaxial screw.It was determined that the yukon oct polyaxial screw had no cause to the adverse event and that the device did not malfunction.Therefore, this device is a concomitant product.

• Brand Name: POLYAXIAL SCREW; SIZE 3.5X14 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9169098
• Report Number: 3004774118-2019-00119
• Device Sequence Number: 3107717
• Product Code: NKG
• UDI-Device Identifier: 10888857349315
• UDI-Public: 10888857349315
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: 7601-03514
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 10/24/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: Other