MAUDE Adverse Event Report: K2M, INC. DRIVER HEIGHT/ANGLE; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7501-90025
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A company representative reported that a capri small expandable height/angle driver jammed during intra-operative expansion of a cage.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.
Additional Manufacturer Narrative
H6 codes have been updated to reflect receipt of the device and conclusion of the investigation.
Event or Problem Description
A company representative reported that a capri small expandable height/angle driver jammed during intra-operative expansion of a cage.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: DRIVER HEIGHT/ANGLE
• 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: 14949115
• Report Number: 3004774118-2022-00261
• Device Sequence Number: 4557747
• Product Code: MQP
• UDI-Device Identifier: 10888857361911
• UDI-Public: 10888857361911
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171704
• 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): 10/03/2022

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: 7501-90025
• Device Catalogue Number: 7501-90025
• Device Lot Number: PCCT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 10/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown