MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS CANNULATED POLYAXIAL SCREW 5.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM

Model Number 48285545

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 05/03/2017

Event Type  malfunction  

Event Description

It was reported that; screw lost the polyaxiality.In the intraoperative moment, the rigidity of the screw was identified.

Manufacturer Narrative

Method: visual inspection, functional inspection, device history review, complaint history review, risk assessment.The screw was returned with some markings and deformation however it did not affect screw functionality.Per functional test, the screw functions as intended.Manufacturing history was reviewed and no issues were identified.The device functioned as expected, the reported event could not be duplicated.

Event Description

It was reported that; screw lost the polyaxiality.In the intraoperative moment, the rigidity of the screw was identified.

• Brand Name: MANTIS CANNULATED POLYAXIAL SCREW 5.5 X 45 MM
• Type of Device: PEDICLE SCREW SPINAL 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: 6652076
• MDR Text Key: 78054085
• Report Number: 0009617544-2017-00251
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 04546540514516
• UDI-Public: (01)04546540514516
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K061813
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 48285545
• Device Catalogue Number: 48285545
• Device Lot Number: 140744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2014
• 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 Weight: 72