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

Model Number	48289999
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that six days after the initial surgery, an es2 blocker migrated from its respective screw.The surgeon plans on revising the patient.
Additional Manufacturer Narrative
Visual: visual inspection showed no rod indentation marks.There are chattering marks around most of the underside of the blocker.Functional: functional inspection was performed and found that the blocker properly engaged to screw head as intended.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.Es2 surgical technique was reviewed and the following was found relevant: insert the torque wrench or audible torque wrench through the counter torque tube to engage the blocker.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.If using the audible torque wrench, the blocker is completely tightened to 12nm when the audible torque wrench clicks once.As there are chattering marks around the bottom of the blocker and no rod indentation marks, the blocker was most likely not properly final tightened to 12nm.The most likely cause of the reported event was determined to be under tightening of blocker into tulip head during final tightening.
Event or Problem Description
It was reported that six days after the initial surgery, an es2 blocker migrated from its respective screw.The surgeon plans on revising the patient.Update: patient was revised on (b)(6) 2021.

• Brand Name: MANTIS BLOCKER
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11610891
• Report Number: 0009617544-2021-00052
• Device Sequence Number: 3086218
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 48289999
• Device Catalogue Number: 48289999S
• Device Lot Number: 4K3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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