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 Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
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, device history review, complaint history review, risk assessment result: the reported event was confirmed.The screw was returned in 2 pieces as the tulip head was disengaged from the thread body.There was deformation on the bottom of the tulip head, on the thread body head and on the cannula opening.Manufacturing history was reviewed and no issues were identified.Conclusion: a root cause of the screw loosing its polyaxility was determined to be inserting the screw too deep into the bone.
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: 6652074
• Report Number: 0009617544-2017-00250
• Device Sequence Number: 1150026
• 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?: Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 72