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

Model Number	48289999
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot additional information- the following lot numbers were also provided as potentially being this device: wjt, wd6, wzc.Additional information has been requested.If additional information is received, a supplemental report will be provided.
Event or Problem Description
It was reported that two mantis screws and a mantis redux blocker migrated post-operatively.Two months after initial surgery, the patient experienced a bone fracture after excessive hip movement/ rotation that caused the two screws and blocker to become loose.The patient did not fuse and revision surgery was performed.This report represents the blocker.
Event or Problem Description
It was reported that two mantis screws and a mantis redux blocker migrated post-operatively.Two months after initial surgery, the patient experienced a bone fracture after excessive hip movement/rotation that caused the two screws and blocker to become loose.The patient did not fuse and revision surgery was performed.This report represents the blocker.
Additional Manufacturer Narrative
D.3: manufacturing entity was corrected from 'stryker spine-france' to 'stryker spine-us' d.4 was previously reported with 4 possible lots and the record has been updated to reflect the lot received.D.9 was updated to reflect product return.H.4 was updated to reflect manufacturing date.
Additional Manufacturer Narrative
Visual inspection noted indentations on the blocker which indicate that the blocker may have been over-tightened during the initial surgery or was removed and re-implanted during the initial surgery.Device history records and complaint history were reviewed and no relevant manufacturing issues or similar complaints were identified.The most likely cause of the reported event is multifactorial: excessive movement by patient post-operatively, post-operative trauma, poor bone quality, non-fusion after 2 years, improper construct.
Event or Problem Description
It was reported that two mantis screws and a mantis redux blocker migrated post-operatively.Two months after initial surgery, the patient experienced a bone fracture after excessive hip movement/rotation that caused the two screws and blocker to become loose.The patient did not fuse and revision surgery was performed.This report represents the blocker.

• 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: 10083172
• Report Number: 0009617544-2020-00075
• Device Sequence Number: 11492052
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• Combination Product (Y/N): N
• PMA/510(K) Number: K092631
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 48289999
• Device Catalogue Number: 48289999
• Device Lot Number: WD7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 07/20/2020; 08/31/2020
• Initial Report FDA Received Date: 05/22/2020
• Supplement Report FDA Received Date: 08/13/2020; 12/02/2020
• 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
• Patient Weight: 60