MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number	482317540
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; tulip head disengaged from the screw.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no issues were identified.Tulip disengagement was confirmed via visual inspection the most likely root cause of the event is determined to be use/patient's factor such as application of extensive force during final tightening and/or hard bone quality.
Event or Problem Description
It was reported that; tulip head disengaged from the screw.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 40 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: 6358170
• Report Number: 3005525032-2017-00017
• Device Sequence Number: 648266
• Product Code: MNI
• UDI-Device Identifier: 04546540562340
• UDI-Public: (01)04546540562340
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/24/2017

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: 482317540
• Device Lot Number: B14895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/31/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 59