MAUDE Adverse Event Report: K2M, INC. PLATE, 2 LEVEL; SIZE 38 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	AA01-42F38V
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the locking mechanism of an ozark level 2 plate wouldn't turn intra-operatively, during final tightening.The procedure was completed successfully by replacing the plate.No adverse consequences nor medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection was performed, and deformation was observed on the inside of the securing mechanism/screw driver interface.This deformation confirms report that the driver was rotating in the securing mechanism and indicates that the securing mechanism would not rotate.Additionally, wear is observed on the top and bottom of the screw holes.Wear on top is on the opposite side as the wear on the underside.The wear observed on the screw holes is most likely from the screw wearing on the plate during screw insertion.Wear location and degree indicates screw(s) were over angulated with respect to the plate.Functional inspection was performed without any screws inserted.All 3 securing mechanisms were able to be closed and opened without difficulty, indicating that the securing mechanism jamming was due to an additional factor other than the plate.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Upon correspondence with the field representative, it was communicated that the size 10 tapered screwdriver was rotating in the securing mechanism, and excessive forces were applied to attempt to lock the securing mechanism.It was also communicated that the patient had hard bone.The device surgical technique guide states that over angulation of screws may result in inability to lock cover.The most likely root cause of the reported event was determined to be due to the over angulation of the screws.Functional inspection confirmed securing mechanism functions as intended without screws.Wear observed during visual inspection indicates screws were over angulated during insertion.Hard bone may have increased difficulty of screw insertion, which may have contributed to the event as well.
Event or Problem Description
It was reported that the locking mechanism of an ozark level 2 plate would not turn intra-operatively, during final tightening.The procedure was completed successfully by replacing the plate.No adverse consequences nor medical intervention were reported.

• Brand Name: PLATE, 2 LEVEL; SIZE 38 MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• 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: 12268313
• Report Number: 3004774118-2021-00239
• Device Sequence Number: 11480894
• Product Code: KWQ
• UDI-Device Identifier: 10888857401570
• UDI-Public: 10888857401570
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172104
• 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): 11/18/2021

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: AA01-42F38V
• Device Catalogue Number: AA01-42F38V
• Device Lot Number: JMAB
• 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: 07/07/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 08/03/2021
• Supplement Report FDA Received Date: 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2019
• 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: Unknown