MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 80MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	482318580
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during final tightening of the blocker to the rod/screw construct the surgeon felt a loosening of the construct.Upon further examination it was noted that the tulip head became dissociated from the screw shaft.The screw was removed easily and a new screw was placed and final tightened without any issues or delays.
Event or Problem Description
It was reported that; during final tightening of the blocker to the rod/screw construct the surgeon felt a loosening of the construct.Upon further examination it was noted that the tulip head became dissociated from the screw shaft.The screw was removed easily and a new screw was placed and final tightened without any issues or delays.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 80MM
• 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: 6681582
• Report Number: 3005525032-2017-00076
• Device Sequence Number: 19236322
• Product Code: MNH
• UDI-Device Identifier: 04546540598653
• UDI-Public: (01)04546540598653
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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 Model Number: 482318580
• Device Catalogue Number: 482318580
• Device Lot Number: B58631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 06/09/2017
• Supplement Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 10/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR