MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 6.5X40 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	E5111-06540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician report that the extended tab of an everest xt fenestrated polyaxial screw fractured unevenly during surgery.The incision site was increased to better visualize the tulip and the remaining fragment of the tab was removed successfully following a 15-minute surgical delay.There was no adverse consequence to the patient.
Event or Problem Description
A physician report that the extended tab of an everest xt fenestrated polyaxial screw fractured unevenly during surgery.The incision site was increased to better visualize the tulip and the remaining fragment of the tab was removed successfully following a 15-minute surgical delay.There was no adverse consequence to the patient.
Additional Manufacturer Narrative
Device evaluation could not be performed.The device remains implanted and the fractured tab was discarded.Manufacturing records and complaint history could not be reviewed because a lot number was not provided.A review of complaint history associated with the subject catalog number was performed, and no adverse trends were observed.The cause of the reported event could not be determined conclusively.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE 6.5X40 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10391960
• Report Number: 3004774118-2020-00168
• Device Sequence Number: 19557888
• Product Code: NKB
• UDI-Device Identifier: 10888857212596
• UDI-Public: 10888857212596
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151727
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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: E5111-06540
• Device Catalogue Number: E5111-06540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1