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

Model Number 6201-06545

Device Problems Crack (1135); Fracture (1260); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/25/2021

Event Type  Injury  

Event 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.

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• MDR Report Key: 12037302
• MDR Text Key: 257473231
• Report Number: 3004774118-2021-00183
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10888857164550
• UDI-Public: 10888857164550
• Combination Product (y/n): N
• PMA/PMN Number: K143334
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention