MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM MONOAXIAL SCREW DIA 6.5 X 50 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482306550
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/15/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that; after a revision surgery the xia 3 screw broke under the tulip head.
Additional Manufacturer Narrative
Results: the ifu states that implanted devices may fatigue as they are not meant to indefinitely withstand the normal loads of bone and are only meant to aid in support during fusion of the vertebrae.Inspection of the fracture surface confirmed the presence of beach marks, which is consistent with fatigue fracture.It was confirmed that the patient had fused prior to the fracture, so the device had served its purpose.Conclusion: the most likely cause of the customer reported event is fatigue fracture due to prolonged implantation.
Event or Problem Description
It is reported that; after a revision surgery the xia 3 screw broke under the tulip head.

• Brand Name: XIA 3 TITANIUM MONOAXIAL SCREW DIA 6.5 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: 5784008
• Report Number: 3005525032-2016-00083
• Device Sequence Number: 599410
• Product Code: MNH
• UDI-Device Identifier: 04546540561510
• UDI-Public: (01)04546540561510
• Combination Product (Y/N): N
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2016

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: 482306550
• Device Lot Number: B58151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2016
• Supplement Report FDA Received Date: 09/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 74