MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482318590
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the surgeon of the hospital informed us that during a surgery he wanted to screw with the torque wrench the screw with the locking screw.The tulip of the screw has cracked and the screws could not be turned tight.The screw was removed and a new screw was used.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.A visual inspection confirmed deformation of the inner threads of the tulip.No relevant manufacturing issues were identified as all units met specifications.The most likely cause of the customer reported event is misalignment of the blocker during insertion, resulting in cross threading of the devices.
Event or Problem Description
It was reported that; the surgeon of the hospital informed us that during a surgery he wanted to screw with the torque wrench the screw with the locking screw.The tulip of the screw has cracked and the screws could not be turned tight.The screw was removed and a new screw was used.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 90MM
• 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: 6209318
• Report Number: 3005525032-2016-00162
• Device Sequence Number: 416113
• Product Code: MNH
• UDI-Device Identifier: 04546540598660
• UDI-Public: (01)04546540598660
• Combination Product (Y/N): N
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2017

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: 482318590
• Device Lot Number: B23533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/28/2016
• Supplement Report FDA Received Date: 02/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1