MAUDE Adverse Event Report: K2M, INC. MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE 8.5X70 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	6201-08570
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in patient.
Event or Problem Description
It was reported that two mesa 2 polyaxial screws migrated post-operatively.The patient came in for a post op visit and images showed rods had disengaged from screws at pelvic level bilaterally.Fusion has been achieved.It is unknown if revision surgery has been scheduled.This report represents the second of the two screws.
Event or Problem Description
It was reported that two mesa 2 polyaxial screws migrated post-operatively.The patient came in for a post op visit and images showed rods had disengaged from screws at pelvic level bilaterally.There are no plans for revision as patient is fused and asymptomatic at this time.This report represents the second of the two screws.
Additional Manufacturer Narrative
Functional, dimensional, and material analysis could not be performed as the device was not returned.However, x-rays were provided by the rep.Upon review, it was observed that bilateral screws at the caudal end of the construct had slipped axially along their associated rods.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.It is possible that cantilever forces at the caudal end of the construct may have overloaded the capture strength of the screws, resulting in rod slippage.It is also possible for incorrect instrumentation to apply an insufficient amount of torque to capture the rod.However, as no devices were available for evaluation, the root cause could not be determined conclusively.

• Brand Name: MESA 2 DEFORMITY POLYAXIAL SCREW; SIZE 8.5X70 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• MDR Report Key: 10102552
• Report Number: 3004774118-2020-00097
• Device Sequence Number: 2653511
• Product Code: NKB
• UDI-Device Identifier: 10888857165793
• UDI-Public: 10888857165793
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K143334
• 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): 07/29/2020

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: 6201-08570
• Device Catalogue Number: 6201-08570
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 05/29/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 98