MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS LONG CONSTRUCT HEX STRAIGHT ROD 6.0 X 480MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 48487480

Device Problem Fracture (1260)

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

Event Date 12/01/2020

Event Type  Injury  

Event Description

It was reported that approximately 3 weeks following the initial surgery, an es2 integrated blade screw and mantis straight rod fractured post-operatively.Revision surgery has been performed.This record represents the mantis straight rod.

Event Description

It was reported that approximately 3 weeks following the initial surgery, an es2 integrated blade screw and mantis straight rod fractured post-operatively.Revision surgery has been performed.This record represents the mantis straight rod.

Manufacturer Narrative

Corrected data: d.9.And h.3.Have been corrected to reflect that the device was not received.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.While the rod was not returned, the screw was returned with the tulip disengaged from the screw shank.The tulip locking ring was deformed.The shank bulb had a deep and angled rod indentation, indicative of tulip angulation and overtightening.There is also a sharp angulation midway through the shank bulb indentation, indicating that rod tightening was performed at least twice at tulip head/rod over angulation and tulip head/rod severe over angulations.The most likely cause of fracture in rod is excess stress on the rod due to overtightening of the blocker and sharp angulation within tulip head.H3 other text : device was not returned.

• Brand Name: MANTIS LONG CONSTRUCT HEX STRAIGHT ROD 6.0 X 480MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11069527
• MDR Text Key: 223590264
• Report Number: 0009617544-2020-00211
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540671837
• UDI-Public: 04546540671837
• Combination Product (y/n): N
• PMA/PMN Number: K092631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2021

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
• Device Operator: Health Professional
• Device Model Number: 48487480
• Device Catalogue Number: 48487480
• Device Lot Number: V48
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/22/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention