MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 45MM; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number	482318545
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/14/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screw splayed open during blocker insertion.
Additional Manufacturer Narrative
Method: complaint history review; risk assessment.Results: visual inspection, functional inspection and device history could not be performed because no device was returned.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: the root cause cannot be confirmed, as the product was not returned.
Event or Problem Description
It was reported that the screw splayed open during blocker insertion.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 45MM
• 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: 5574741
• Report Number: 3005525032-2016-00037
• Device Sequence Number: 16225926
• Product Code: MNH
• UDI-Device Identifier: 04546540598592
• UDI-Public: (01)04546540598592
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2016

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: 482318545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2016
• Supplement Report FDA Received Date: 07/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1