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

Model Number 48289999

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 04/16/2020

Event Type  Injury  

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 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 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.

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.

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10083172
• MDR Text Key: 191842755
• Report Number: 0009617544-2020-00075
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540671431
• UDI-Public: 04546540671431
• Combination Product (y/n): N
• PMA/PMN Number: K092631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 60