MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482316545
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/28/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that during a surgery procedure the surgeon observed that the rod couldn't be fixed into the screw, as specified.Although full tightening of the screw a part of ployaxiality still remains.A replacement was available to complete the surgery.
Additional Manufacturer Narrative
Method: visual analysis, functional analysis, device history review, complaint history review, risk assessment.Result: the screw was inspected and there was some debris and deformities.This did not affect the performance of the device during functional inspection.The device functioned as expected and the reported complaint could not be duplicated.No relevant manufacturing issues were identified as all units met stryker specifications.Conclusion: root cause could not be definitively determined as the reported complaint could not be confirmed as the device was found to be fully functional.
Event or Problem Description
It is reported that during a surgery procedure the surgeon observed that the rod couldn't be fixed into the screw, as specified.Although full tightening of the screw a part of polyaxiality still remains.A replacement was available to complete the surgery.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 6.5 X 45 MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 5912091
• Report Number: 3005525032-2016-00094
• Device Sequence Number: 10909786
• Product Code: MNH
• UDI-Device Identifier: 04546540562241
• UDI-Public: (01)04546540562241
• Combination Product (Y/N): N
• PMA/510(K) Number: K071373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2016

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 Catalogue Number: 482316545
• Device Lot Number: B59321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2016
• Supplement Report FDA Received Date: 11/03/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1