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

Model Number 48289999

Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Information (3190)

Event Date 08/11/2017

Event Type  Injury  

Event Description

It was reported that; surgeon has a patient he did posterior lumbar fusion a few weeks ago.Locking nut on one screw has detached.Surgeon is concerned torque drivers are out of calibration.Order all new torque drivers for his sets.

Manufacturer Narrative

No issue was reported on this device as this is a concomitant product.The device was inspected visually and no issue was identified.Conclusion: no issue was reported on this device as this is a concomitant product.

Event Description

It was reported that; surgeon has a patient he did posterior lumbar fusion a few weeks ago.Locking nut on one screw has detached.Surgeon is concerned torque drivers are out of calibration.Order all new torque drivers for his sets.

• Brand Name: MANTIS REDUX BLOCKER
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: marta koutsogiannis ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6852701
• MDR Text Key: 85438540
• Report Number: 0009617544-2017-00352
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540671431
• UDI-Public: (01)04546540671431
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48289999
• Device Catalogue Number: 48289999
• Device Lot Number: UXZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention