MAUDE Adverse Event Report: K2M, INC. LOCKING SCREW - HEIGHT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7501-10001-G1
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the height locking set screw of a capri small expandable cage would not "torque out" during implantation.The surgeon removed the height locking set screw from the cage and then replaced it with a back-up height locking set screw but the same issue persisted.The surgeon then removed and replaced the cage with a back-up device.There were no adverse consequences to the patient and the procedure was completed successfully with a 10-minute surgical delay.This report captures the back-up height locking set screw.
Additional Manufacturer Narrative
The height locking set screw showed significant deformation.The threads of the screw were dented and severely stripped.The top of the screw and hex grooves were dented and scratched.For functional testing, a new height screw that properly functioned with unused cages was tested with the returned corpectomy cage; the screw would not advance through the threads in the cage housing.The threads in the cage housing did not display obvious deformation, but functional testing indicates the threads in the cage housing were deformed and would not align with the screw.Device history records were reviewed for this lot, no relevant manufacturing issues were identified.Complaint history records were reviewed for this catalog number, a similar complaint was identified.The rep reported they believed that the surgeon had cross-threaded the screw and deformed the threads with force.The most likely root cause is cross-threading of the height set screw.The screw was likely cross-threaded and the threads of both the screw and the cage housing were deformed through the subsequent application of force.
Event or Problem Description
It was reported that the height locking set screw of a capri small expandable cage would not "torque out" during implantation.The surgeon removed the height locking set screw from the cage and then replaced it with a back-up height locking set screw but the same issue persisted.The surgeon then removed and replaced the cage with a back-up device.There were no adverse consequences to the patient and the procedure was completed successfully with a 10-minute surgical delay.This report captures the back-up height locking set screw.

• Brand Name: LOCKING SCREW - HEIGHT
• Common Device Name: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 14291856
• Report Number: 3004774118-2022-00175
• Device Sequence Number: 20160994
• Product Code: MQP
• UDI-Device Identifier: 10888857371484
• UDI-Public: 10888857371484
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180665
• 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): 08/19/2022

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: 7501-10001-G1
• Device Catalogue Number: 7501-10001-G1
• Device Lot Number: GAEA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2017
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 138 KG