MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482802645

Device Problem Migration (4003)

Patient Problem Injury (2348)

Event Date 04/16/2020

Event Type  Injury  

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 first of the two screws.

Manufacturer Narrative

D.3: manufacturing entity was corrected from 'stryker spine-france' to 'stryker spine-us'.Section d was updated to reflect product information upon product return.H.4 was updated to reflect manufacturing date.

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 first of the two screws.

Manufacturer Narrative

Visual inspection of the tulip found it to be jammed.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 first of the two screws.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 6.5X45MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 10083122
• MDR Text Key: 191842555
• Report Number: 0009617544-2020-00073
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K122845
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 482802645
• Device Lot Number: 16D709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/22/2020
• Supplement Dates Manufacturer Received: 07/20/2020; 08/31/2020
• Supplement Dates FDA Received: 08/13/2020; 12/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 60