MAUDE Adverse Event Report: K2M, INC. FIXED ANGLE BONE SCREW DIAM 4.0 X 14MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	48674014
Medical Device Problem Codes	Material Deformation (2976); Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a 'little damage' to the head of a reflex hybrid fixed angle bone screw which caused the screw to pass through the plate intra-operatively.Surgery was successfully completed with another screw and a 30 minute surgical delay.No adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that there was a 'little damage' to the head of a reflex hybrid fixed angle bone screw which caused the screw to pass through the plate intra-operatively.Surgery was successfully completed with another screw and a 30 minute surgical delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Visual inspection: the rib on the top of the screw was damaged and deformed, most likely from being driven through the locking ring on the plate.Device and complaint history records were reviewed, and no relevant manufacturing issues or similar complaints were identified.From the surgical technique: the amount of torque required to complete final tightening can be done with a single hand, and should not exceed one quarter turn once the screw is underneath the ring.In addition to the tactile sensation of the locking ring closing over the bone screw head, final screw locking should also be confirmed visually with the ring being clearly visible over the bone screw head.It is unknown how many turns were applied after the locking ring became visible.The damage on the screw is consistent with being driven below the locking ring.Most likely root cause is excessive torque or too many turns applied to the screw once the locking ring became visible.

• Brand Name: FIXED ANGLE BONE SCREW DIAM 4.0 X 14MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10382248
• Report Number: 0009617544-2020-00134
• Device Sequence Number: 3168525
• Product Code: KWQ
• UDI-Device Identifier: 04546540392954
• UDI-Public: 04546540392954
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K040261
• 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): 10/27/2020

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: 48674014
• Device Catalogue Number: 48674014
• Device Lot Number: 3WP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1