MAUDE Adverse Event Report: K2M, INC. THORACIC PROBE; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	101-90054
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Status and location of the device is unknown.
Event or Problem Description
It was reported that a denali thoracic probe tip fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully.
Event or Problem Description
It was reported that a denali thoracic probe tip fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully with a 5 minute surgical delay.
Additional Manufacturer Narrative
Correction to b5: corrected from 'it was reported that a denali thoracic probe tip fractured intra-operatively.There were no adverse consequences to the patient and the procedure was completed successfully' to 'it was reported that a denali thoracic probe tip fractured intra- operatively.There were no adverse consequences to the patient and the procedure was completed successfully with a 5 minute surgical delay'.Visual inspection: device was inspected and found to have a fractured distal tip between the 30 mm and 40 mm markings.Little to no plastic deformation was detected indicating brittle fracture had occurred.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.Denali mini surgical technique was reviewed and the following relevant information was identified: the desired entry point of the pedicle is chosen and then perforated with an awl to expose the underlying cancellous bone.The entry point is then cannulated with the small pedicle probe.The small pedicle probe is advanced to the appropriate depth, as determined by the surgeon.The correct insertion of the instrument will allow the tip of the probe to follow a path of least resistance, reducing the potential of perforating the pedicle walls.The small pedicle probe is laser etched at 10 mm increments from 10-50 mm, indicating the depth to which the probe has been inserted.These markings also help the surgeon assess proper drill and screw length.Fracture surface was angled and uneven and likely occurred due to excessive bending stress.

• Brand Name: THORACIC PROBE
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 9349853
• Report Number: 3004774118-2019-00143
• Device Sequence Number: 16853216
• Product Code: LXH
• UDI-Device Identifier: 10888857009868
• UDI-Public: 10888857009868
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K181119
• 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): 02/21/2020

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 Catalogue Number: 101-90054
• Device Lot Number: ADPP
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 01/26/2020
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1