MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 4.5 X 40 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.

Model Number	481322040
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgery was done in (b)(6) 2017, the patient came back for 3 week follow up with no issues and at 2 month follow up, the rod had slipped out of the tulip head of the screw.The locking cap is still in the screw head, but the rod is no longer engaged into the tulip head.The patient has not come back to the or for surgery.The surgeon is monitoring the patient.No adverse health consequences has been reported.
Event or Problem Description
It was reported that the surgery was done in (b)(6) of 2017, the patient came back for 3 week follow up with no issues and at 2 month follow up, the rod had slipped out of the tulip head of the screw.The locking cap is still in the screw head, but the rod is no longer engaged into the tulip head.The patient has not come back to the or for surgery.The surgeon is monitoring the patient.No adverse health consequences has been reported.
Additional Manufacturer Narrative
Method: risk assessment; x-rays analysis.Results: the reported event was confirmed via correspondence with the sales rep and surgeon, along with x ray review.Visual, dimensional and functional analysis could not be performed as the device was not returned.It remains implanted.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the most likely root cause is the rod was not properly seated in the tulip head which led to loosening.

• Brand Name: XIA 4.5 X 40 VITALLIUM PREBENT AND PRECUT ROD W/OUT HEX
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7234904
• Report Number: 0009617544-2018-00026
• Device Sequence Number: 143973
• Product Code: MNH
• UDI-Device Identifier: 07613327003369
• UDI-Public: (01)07613327003369
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K050461
• 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): 04/13/2018

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: 481322040
• Device Catalogue Number: 481322040
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/05/2018
• Supplement Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 02/01/2018
• Supplement Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1