MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317550
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/27/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Per reported event; the polyaxial tulip head broke off of the screw while inserting the blocker.
Additional Manufacturer Narrative
Method: risk assessment: results: review of the correspondence confirms that the tulip disengagement occurred on the screw during final tightening.The sales representative confirmed that the torque wrench and anti-torque key were used as directed, however since the product is not available for evaluation.Conclusion: the cause of this issue is likely to be multi-factorial in nature and cannot be conclusively determined.
Event or Problem Description
Per reported event; the polyaxial tulip head broke off of the screw while inserting the blocker.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 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: 5464084
• Report Number: 3005525032-2016-00020
• Device Sequence Number: 405735
• Product Code: MNH
• UDI-Device Identifier: 04546540562364
• UDI-Public: 04546540562364
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• 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): 01/28/2016

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: 482317550
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/26/2016
• Supplement Report FDA Received Date: 06/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1