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

Model Number	48289999
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains in patient.
Event or Problem Description
It was reported that during the procedure, a mantis redux blocker was inadvertently left in the patient.An xray was performed and an additional set screw was observed.Revision is scheduled in the future.
Additional Manufacturer Narrative
These fields have been corrected following receipt of additional communication from the field: b1, b2, b5, h1.The device remains implanted and is unavailable for evaluation.Device history record review could not be performed as a valid lot code was not provided and could not be obtained.A review of complaint history associated with the subject catalog number was performed and no adverse trends were observed.Additional correspondence with the field representative: "the doctor misunderstood that they probably did not deploy a blocker in screw head and they inserted a new blocker on the top of the blocker that had already been in place." from mantis surgical technique: improper selection, placement, positioning and fixation of these devices may result in unusual stress conditions reducing the service life of the implant.The most likely root cause of the reported event is user error.
Event or Problem Description
It was reported that during the procedure, a mantis redux blocker was inadvertently left in the patient.An x-ray was performed and an additional set screw was observed.Revision surgery is not planned.

• 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: 11872852
• Report Number: 0009617544-2021-00088
• Device Sequence Number: 19044415
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• 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: 2021
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 48289999
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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
• Patient Age: 76 YR
• Patient Weight: 80