MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS LONG CONSTRUCT HEX STRAIGHT ROD 6.0 X 90MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48487090
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	09/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned and therefore could not be evaluated.
Event or Problem Description
A mantis rod migrated post-operatively.Revision surgery was performed.
Event or Problem Description
A mantis rod migrated post-operatively.Revision surgery was performed.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device and complaint history records were reviewed, and no relevant manufacturing or similar complaints were identified.Per surgical technique: place the anti-torque key around the screw head.Place the torque wrench through the anti-torque key until it is guided into the blocker.The torque wrench indicates the optimal torque force that must be applied to the implant for final tightening.Line up the two arrows to achieve the final tightening torque of 12nm.Note: do not exceed 12nm during final tightening.Torque wrench was used during the initial surgery and blockers were tightened to 12nm.It is unknown if the length of the rod used was adequate for the construct.X-ray images were not provided.It is unknown if the rod was reduced or was properly seated during initial surgery.Too short rod length can cause the rod to improperly seat in the tulip which may result in the migration of rod post op.The es2 surgical technique recommends the user to ensure that the rod overhangs the last screw head to allow for secure fixation.Due to lack of information, an exact root cause of reported event could not be determined.

• Brand Name: MANTIS LONG CONSTRUCT HEX STRAIGHT ROD 6.0 X 90MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9131615
• Report Number: 0009617544-2019-00112
• Device Sequence Number: 418915
• Product Code: NKB
• UDI-Device Identifier: 04546540671714
• UDI-Public: 04546540671714
• Combination Product (Y/N): N
• PMA/510(K) Number: K092631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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 Catalogue Number: 48487090
• Device Lot Number: SHX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 12/20/2019
• 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
• Patient Age: 33 YR