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

Model Number	7601-03526
Medical Device Problem Codes	Mechanical Jam (2983); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that, during removal, two yukon polyaxial screws, "had locked in place so it was impossible to remove with a driver" and that, "it was like the head was going to come off of the screw shank." the reason for device removal has not been provided.This report captures the first of two screws.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.This issue may have been caused by multiple factors-such as, excessive force placed on tulip, over angulation during removal, patient biomaterial in the tulip, etc.However, as the device was not available for investigation, a root cause cannot be determined conclusively.H3 other text: status and location of the device is unknown.
Event or Problem Description
A company representative reported that, during removal, two yukon polyaxial screws, "had locked in place so it was impossible to remove with a driver" and that, "it was like the head was going to come off of the screw shank." the reason for device removal has not been provided.This report captures the first of two screws.

• 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: 11609553
• Report Number: 3004774118-2021-00097
• Device Sequence Number: 4009472
• Product Code: NKG
• UDI-Device Identifier: 10888857349377
• UDI-Public: 10888857349377
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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