MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS REDUX BLOCKER; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482804645
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Injury (2348)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been explanted but will not be returned.
Event or Problem Description
Company representative reported that an es2 integrated blade screw size l 6.5x45mm migrated/pulled-out "13-24 months" post-operatively.Revision surgery was performed and the devices were replaced.
Additional Manufacturer Narrative
Corrected data: d.6.Date of implant updated from blank to ' on (b)(6) 2017'.D.6.Date of explant updated from blank to ' on (b)(6) 2019'.Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.Per instructions for use: while the expected life of spinal implant components is difficult to estimate, it is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.However, due to the many biological, mechanical and physicochemical factors which affect these devices but cannot be evaluated in vivo, the components cannot be expected to indefinitely withstand the activity level and loads of normal healthy bone.These implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed.Removal may also be recommended in other cases, such as: corrosion with a painful reaction.Migration of the implant, with subsequent pain and/or neurological, articular or soft tissue lesions.Pain or abnormal sensations due to the presence of the implants.Infection or inflammatory reactions.Reduction in bone density due to the different distribution of mechanical and physiological stresses and strains.Failure or mobilization of the implant.Based on the available information, the most likely cause of reported event is normal wear over the time.
Event or Problem Description
Company representative reported that during an extension of fusion, an es2 blocker was found to migrated/pulled-out.The device was replaced.
Additional Manufacturer Narrative
Corrected data: b.1.Has been updated from 'adverse event and product problem' to 'product problem'.B.2.Has been updated from 'required intervention to prevent permanent impairment/damage (devices)' to 'blank'.B.5.Stryker has received additional information clarifying that the event occurred to a blocker.Additional information also clarifies the surgery was an extension of fusion surgery and not a revision surgery.B.5.Has been updated to reflect the new device information.D.1.Has been updated from 'es2 integrated blade screw size l 6.5x45mm' to 'mantis redux blocker'.D.4.Catalog has been updated from '482804645' to '48289999'.D.4.Gtin has been updated from (b)(4).G.5.Has been updated from 'k122845' to 'k092631'.H.1.Has been updated from 'serious injury' to 'malfunction'.H.6.Patient code updated from '2348' to '2199'.
Event or Problem Description
Company representative reported that during an extension of fusion, an es2 blocker was found to migrated/pulled-out.The device was replaced.

• Brand Name: MANTIS REDUX BLOCKER
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9387034
• Report Number: 0009617544-2019-00130
• Device Sequence Number: 16561932
• Product Code: NKB
• UDI-Device Identifier: 07613327002188
• UDI-Public: 07613327002188
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K092631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2020

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: 482804645
• Device Catalogue Number: 48289999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 01/16/2020; 02/27/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 02/13/2020; 03/23/2020
• 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