MAUDE Adverse Event Report: K2M, INC. CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 26-36MM, 0°, 0-20°; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Model Number	7512-21636L0-G3
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative reported that a capri small expandable corpectomy cage, "collapsed a little inside the patient." the patient has been revised.
Event or Problem Description
A company representative reported that a capri small expandable corpectomy cage, "collapsed a little inside the patient." the patient has been revised.
Additional Manufacturer Narrative
The returned device could not be functionally inspected due to the existing damage and remaining tissue.The device was inspected visually.The gold angle locking screw was severely stripped on the back side from over-tightening.The tin coating was removed from the surface along with the top layer of material, revealing uncoated metal underneath.The metal scraped from the surface collected at the end of the stripping damage.The rotational direction of the damage indicates stripping occurred during tightening.Through the windows in the cage housing, the raised grooves of thread height expansion tower were observed to be scratched, damaged, and deformed.The abrasions on the height expansion tower were circumferential (following the length of the grooves) with a slight negative curvature consistent with the tower collapsing.The visible tooth of the height ring exhibited some deformation in the form of dents on its right side.The height pin (inside the cage on top right threaded hole) was severely deformed with a chunk missing that appears to have broken off by brittle fracture.Device history records were reviewed and no relevant manufacturing issues were identified.Complaint history was reviewed and no similar complaints for the reported lot number were identified.To finalize the construct, the angle locking screw and pre-staked height locking screw must both be final tightened to 12 in-lbs (~1.4 n-m).The ous surgical technique guide states that the angle locking screw is to be final tightened using the size 10 non-tapered driver attached to the 12 in-lbs torque limiting handle.The torque limiting handle is designed such that the surgeon will hear a click once the required torque is achieved.Applying torque beyond the required amount may damage the screw and weaken the construct.The most likely root cause is over-tightening of the angle locking screw.The angle locking screw was severely stripped from excessive torque.The loss of material likely weakened the implant, ultimately leading to its collapse within the patient.

• Brand Name: CORPECTOMY CAGE WITH SET SCREW; SIZE 13X16MM, 26-36MM, 0°, 0-20°
• 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: 14342122
• Report Number: 3004774118-2022-00180
• Device Sequence Number: 20467349
• Product Code: MQP
• UDI-Device Identifier: 10888857370944
• UDI-Public: 10888857370944
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K180665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7512-21636L0-G3
• Device Catalogue Number: 7512-21636L0-G3
• Device Lot Number: MVBM-470830
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Unknown