MAUDE Adverse Event Report: MESA 2 DEFORMITY UNIPLANAR SCREW; SIZE Ø5.5X35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6201-35535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
It was reported that the inner collet of three mesa uniplanar screws broke/chipped intra-operatively at t4 and t12.The procedure was completed successfully with a 20 minute surgical delay.No adverse consequences resulted from this event.This record captures the first of the three reported mesa uniplanar screws.
Additional Manufacturer Narrative
Visual, functional, dimensional, and material analysis could not be performed as the device remains implanted in the patient.Device history records and complaint history records could not be reviewed as the lot number was not available.Complaint history was reviewed for the corresponding catalog number, and no adverse trends were identified.The t6 screws both chipped during reduction/derotation with the crickets on- the left screw chipped on lateral side and right screw chipped on medial side.The t12 screw chipped during derotation on the medial side.Communication with the field representative states that the surgeon had to use excessive force and complex maneuvers during derotation since the patient had idiopathic scoliosis, so each body was rotated.It was confirmed during communication that the devices broke during derotation maneuver.As the surgeon had to use excessive and off axis force to achieve proper correction, it is likely that these implants were stressed beyond their capacity during these complex maneuvers.
Event or Problem Description
It was reported that the inner collet of three mesa uniplanar screws broke/chipped intra-operatively at t4 and t12.The procedure was completed successfully with a 20 minute surgical delay.No adverse consequences resulted from this event.This record captures the first of the three reported mesa uniplanar screws.

• Brand Name: MESA 2 DEFORMITY UNIPLANAR SCREW; SIZE Ø5.5X35 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• MDR Report Key: 12159375
• Report Number: 3004774118-2021-00215
• Device Sequence Number: 11931948
• Product Code: NKB
• UDI-Device Identifier: 10888857168398
• UDI-Public: 10888857168398
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143334
• 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): 11/02/2021

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: 6201-35535
• Device Catalogue Number: 6201-35535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/16/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 11/02/2021
• 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