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

Model Number	48285545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screw lost the polyaxiality.In the intraoperative moment, the rigidity of the screw was identified.
Additional 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 or Problem 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
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6652076
• Report Number: 0009617544-2017-00251
• Device Sequence Number: 1150143
• Product Code: MNH
• UDI-Device Identifier: 04546540514516
• UDI-Public: (01)04546540514516
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K061813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 01/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 72