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

Model Number	7601-05030
Medical Device Problem Codes	Material Separation (1562); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a yukon polyaxial screw tulip disengaged post-operatively at t1.Revision surgery is not scheduled at this time.
Additional Manufacturer Narrative
Corrected data: b5.Has been updated to reflect that this was found during inspection and there was no patient involvement.Visual inspection: the device was inspected, and it was observed that the pin and spring components were not intact in the assembly; so the tulip head, shaft, and anvil were free floating.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.As the implant was found disassembled, it is unclear when or how the failure occurred.As a result, the reported failure mode was confirmed, but no root cause for the issue was identified.
Event or Problem Description
It was reported that during inspection, a yukon polyaxial screw tulip was observed to be 'disengaged'.There is no procedure associated with this reported event, no patient involvement, and no adverse consequence has been reported.

• 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: 10756871
• Report Number: 3004774118-2020-00289
• Device Sequence Number: 13734694
• Product Code: NKG
• UDI-Device Identifier: 10888857350021
• UDI-Public: 10888857350021
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7601-05030
• Device Catalogue Number: 7601-05030
• Device Lot Number: KRBR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1