MAUDE Adverse Event Report: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X45 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6201-06545
Medical Device Problem Codes	Crack (1135); Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that post-operatively on x-ray, the mesa 2 deformity polyaxial screw head was noted to be damaged laterally.Revision surgery was performed where the implant was explanted.
Additional Manufacturer Narrative
Visual inspection: deformation was observed on one side of the inner collet extending to the outer collet.A crack was also found on the bottom of the inner collet the screw was returned in an unlocked state.It cannot be determined if this damage was caused during explantation of the device or from other causes.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.A root cause cannot be determined as insufficient information was provided by the site.Possible causes that could have caused collet deformation include external trauma, patient fall, rod slippage, construct design, and/or improper final locking/excessive force during final locking or corrections.
Event or Problem Description
It was reported that post-operatively on x-ray, the mesa 2 deformity polyaxial screw head was noted to be damaged laterally.Revision surgery was performed where the implant was explanted.

• Brand Name: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE Ø6.5X45 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• MDR Report Key: 12037302
• Report Number: 3004774118-2021-00183
• Device Sequence Number: 17331503
• Product Code: NKB
• UDI-Device Identifier: 10888857164550
• UDI-Public: 10888857164550
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143334
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6201-06545
• Device Catalogue Number: 6201-06545
• Device Lot Number: KPHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention