MAUDE Adverse Event Report: K2M, INC. SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X14 MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	8801-04014DA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Hospital disposed of device.
Event or Problem Description
It was reported that the thread of an ozark self-starting variable screw stripped during insertion intra-operatively.The procedure was completed successfully by replacing the screw.No adverse consequences nor surgical delay were reported.
Event or Problem Description
It was reported that the thread of an ozark self-starting variable screw stripped during insertion intra-operatively.The procedure was completed successfully by replacing the screw.No adverse consequences nor surgical delay were reported.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was discarded by customer after the case and was not returned.Device and complaint history records could not be reviewed as a valid lot number was not provided and could not be obtained.It was reported that a portion of the threading of the screw had stripped off from the main body.It was further reported that the screw may have been over angulated and contacting the plate during insertion.The fragment was removed, and the procedure was completed successfully with a different screw.No patient harm occurred.The ozark surgical technique and device ifu were reviewed:¿ note: do not over angulate screws beyond their indicated limit, doing so could result in the inability to lock the cover.Once the screw hole is prepared and the appropriately sized screw is selected, screws can be inserted into the plate using the size 10 tapered driver or the size 10 threaded driver." the most likely cause of the event was determined to be the reported over angulation of the screw during insertion.Over angulation of screw can damage screws, plate, and/or securing mechanism of plate.

• Brand Name: SELF-STARTING, VARIABLE SCREW; SIZE Ø4.0X14 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: 12677426
• Report Number: 3004774118-2021-00322
• Device Sequence Number: 4212512
• Product Code: KWQ
• UDI-Device Identifier: 10888857393363
• UDI-Public: 10888857393363
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 8801-04014DA
• Device Catalogue Number: 8801-04014DA
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 12/28/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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