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

Model Number	48487480
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11069527
• Report Number: 0009617544-2020-00211
• Device Sequence Number: 16958999
• Product Code: NKB
• UDI-Device Identifier: 04546540671837
• UDI-Public: 04546540671837
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention