MAUDE Adverse Event Report: STRYKER SPINE-US MANTIS REDUX REDUCTION SCREW 6.5 X 40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	48289640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the mantis redux reduction screw broke post-operatively.Revision surgery has been performed; however, the shaft of the screw was left inside the patient body.
Event or Problem Description
It was reported that the mantis redux reduction screw broke post-operatively.Revision surgery has been performed; however, the shaft of the screw was left inside the patient body.
Additional Manufacturer Narrative
Visual inspection: the returned device was confirmed to be fractured at its shaft.It was observed that the head of the screw had abnormal rod indentations, indicating that the rod was not properly seated into the tulip.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.The mantis surgical technique states, "improper selection, placement, positioning and fixation of these devices may result in unusual stress conditions reducing the service life of the implant".It is likely that improper rod seating created offloading within the construct, leading to fracture.

• Brand Name: MANTIS REDUX REDUCTION SCREW 6.5 X 40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10781362
• Report Number: 0009617544-2020-00185
• Device Sequence Number: 14424071
• Product Code: NKB
• UDI-Device Identifier: 04546540671189
• UDI-Public: 04546540671189
• 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): 02/25/2021

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: 48289640
• Device Catalogue Number: 48289640
• Device Lot Number: 134338
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 02/25/2021
• 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