MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 4.5 X 60 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX; PEDICLE SCREW SPINAL SYSTEM

Model Number	48130000
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	05/11/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the case was done on (b)(6) 2017.It was found out on (b)(6) 2017 that the rod on one side of a 2 level tlif has migrated out of the screwheads.
Additional Manufacturer Narrative
Method:risk assessment.Result: no lot # was provided, so a manufacturing record review could not be performed.Product has not been returned back for inspection.Conclusion: the definitive root cause cannot be determined from the given information.
Event or Problem Description
It was reported that the case was done on (b)(6) 2017.It was found out on (b)(6) 2017 that the rod on one side of a 2 level tlif has migrated out of the screwheads.

• Brand Name: XIA 4.5 X 60 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6613254
• Report Number: 0009617544-2017-00233
• Device Sequence Number: 849412
• Product Code: MNH
• UDI-Device Identifier: 04546540448897
• UDI-Public: (01)04546540448897
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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: 48130000
• Device Catalogue Number: 481322060
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2017
• Supplement Date Received by Manufacturer: 05/11/2017
• Initial Report FDA Received Date: 06/05/2017
• Supplement Report FDA Received Date: 08/24/2017
• 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