MAUDE Adverse Event Report: STRYKER SPINE-US ES2 HEX STRAIGHT ROD 5.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482807045

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

Visual inspection: visual inspection indicates that rod dent on 2 of the returned blockers is not uniform on both sides of the blocker implying that the rod might not be placed horizontally in the screw head.Review of x-rays also indicates that one of the rods was placed at an angle and may not be fully contacting the blockers.No visual anomaly was noted on 2 blockers.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified.From es2 surgical techniqe: use the counter torque tube as an insertion tube to facilitate the alignment of the blocker within the blades to prevent cross-threading.The counter torque tube can also be used to help direct the rod downward into the screw head if the rod is slightly proud.Final tightening of the blockers is performed using the counter torque tube and the torque wrench.Turn the handle of the torque wrench clockwise to align the two arrows on the torque wrench to achieve the 12nm of torque required to secure the implant construct.Caution: extra caution is advised in the following cases: the rod is not horizontally placed into the screw head, the rod is high in the screw head, and/or an acute convex or concave bend is contoured into the rod.Based on surgical technique and inspection of returned products and x-rays, most likely cause of reported event is rod not fully contacting the blockers in the initial construct / off-loading on blockers.

Event Description

It was reported that 4 mantis redux blockers and 2 rods, implanted in l2/l3, migrated post-operatively.Revision surgery has occurred.This report represents the second of the two rods.

Manufacturer Narrative

Visual inspection: visual inspection indicates that rod dent on 2 of the returned blockers is not uniform on both sides of the blocker implying that the rod might not be placed horizontally in the screw head.Review of x-rays also indicates that one of the rods was placed at an angle and may not be fully contacting the blockers.No visual anomaly was noted on 2 blockers.Device and complaint history records were reviewed and no relevant manufacturing issues or similar complaints were identified as all units met stryker specifications.From es2 surgical technique: use the counter torque tube as an insertion tube to facilitate the alignment of the blocker within the blades to prevent cross-threading.The counter torque tube can also be used to help direct the rod downward into the screw head if the rod is slightly proud.Final tightening of the blockers is performed using the counter torque tube and the torque wrench.Turn the handle of the torque wrench clockwise to align the two arrows on the torque wrench to achieve the 12nm of torque required to secure the implant construct.Extra caution is advised in the following cases: the rod is not horizontally placed into the screw head, the rod is high in the screw head, and/or an acute convex or concave bend is contoured into the rod.Based on surgical technique and inspection of returned products and x-rays, most likely cause of reported event is rod not fully contacting the blockers in the initial construct / off-loading on blockers.

Event Description

It was reported that 4 mantis redux blockers and 2 rods, implanted in l2/l3, migrated post-operatively.Revision surgery has occurred.This report represents the second of the two rods.

• Brand Name: ES2 HEX STRAIGHT ROD 5.5 X 45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10121317
• MDR Text Key: 194164528
• Report Number: 0009617544-2020-00078
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327001464
• UDI-Public: 07613327001464
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482807045
• Device Catalogue Number: 482807045
• Device Lot Number: YDT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention