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

Catalog Number	482318580
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during surgery, the surgeon inserted the screw to the iliac.When the surgeon tightened the blocker of screw, the blocker was pop out.Therefore the surgeon changed the screw to same size ml screw.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The asymmetric thread damage observed on the tulip head.Conclusion: the most likely cause of the reported event was determined to be excessive force by the user.
Event or Problem Description
It was reported that; during surgery, the surgeon inserted the screw to the iliac.When the surgeon tightened the blocker of screw, the blocker was pop out.Therefore the surgeon changed the screw to same size ml screw.

• 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: 6133348
• Report Number: 3005525032-2016-00151
• Device Sequence Number: 13735413
• Product Code: MNH
• UDI-Device Identifier: 04546540598653
• UDI-Public: (01)04546540598653
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2017

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: 482318580
• Device Lot Number: B52199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2016
• Supplement Report FDA Received Date: 01/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Weight: 37