MAUDE Adverse Event Report: STRYKER SPINE-FRANCE MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	48285640
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	08/02/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; on (b)(6) 2015, the patient underwent the surgery (t11-12-l1-3-4, l2 vertebroplasty).On (b)(6) 2016, the patient underwent the removing surgery.The surgeon found that the screw shaft was broken(l4 right).Therefore the surgeon removed the screw and broken piece.
Additional Manufacturer Narrative
Type of reportable event: malfunction.Method: visual analysis, device history review, complaint history review, risk assessment; result: the broken screw was visual inspection and was confirmed to be fractured into two pieces.Fractured piece was returned.No relevant manufacturing issues were found upon dhr review.The event was identified during the removal of the implants after the patient fused.The surgical technique states that the expected life of spinal implant components is finite.These components are made of foreign materials which are placed within the body for the potential fusion of the spine and reduction of pain.Conclusion: the probable root cause of this event is fatigue due to finite expected life of implants.
Event or Problem Description
It was reported that; on (b)(6) 2015, the patient underwent the surgery (t11-12-l1-3-4, l2 vertebroplasty).On (b)(6) 2016, the patient underwent the removing surgery.The surgeon found that the screw shaft was broken (l4 right).Therefore the surgeon removed the screw and broken piece.

• Brand Name: MANTIS CANNULATED POLYAXIAL SCREW 6.5 X 40 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: 5903424
• Report Number: 0009617544-2016-00352
• Device Sequence Number: 493345
• Product Code: MNH
• UDI-Device Identifier: 04546540514561
• UDI-Public: (01)04546540514561
• Combination Product (Y/N): N
• PMA/510(K) Number: K061813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2016

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 Catalogue Number: 48285640
• Device Lot Number: 140329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2016
• Supplement Report FDA Received Date: 11/04/2016
• 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 Age: 16 YR