MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø7.5X55 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	E5111-07555
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an everest xt polyaxial screw broke during insertion into dense bone at s1.The remaining portion was left in the patient.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences nor medical intervention was reported.
Event or Problem Description
It was reported that an everest xt polyaxial screw broke during insertion into dense bone at s1.The remaining portion was left in the patient.The procedure was completed successfully with an unknown amount of surgical delay.No adverse consequences nor medical intervention was reported.
Additional Manufacturer Narrative
The returned screw showed a clean fracture directly below the tulip.No other visual deformations were identified.An x-ray was provided of the fractured screw in the patient's body.The x-ray shows the shaft of the screw implanted into the bone, with the tulip (connected to the extended tab) separated.It was confirmed the screw shaft was left in the patient, while the fractured piece of the screw (tulip and extended tab) was returned for evaluation.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The most likely root cause of the reported event is due to the patient's very dense bone.Excessive torsional force may have been applied in order to insert the implant further into the bone, resulting in a fracture below the tulip of the screw.

• Brand Name: POLYAXIAL SCREW, EXTENDED TAB, FENESTRATED; SIZE Ø7.5X55 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12302300
• Report Number: 3004774118-2021-00243
• Device Sequence Number: 17136339
• Product Code: NKB
• UDI-Device Identifier: 10888857212800
• UDI-Public: 10888857212800
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K151727
• 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): 11/23/2021

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: E5111-07555
• Device Catalogue Number: E5111-07555
• Device Lot Number: NXUD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/12/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 08/10/2021
• Supplement Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 200 KG