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

Model Number	482318545
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screw tulip splayed open while blocker was being final tightened with a standard torque wrench.The delay was one minute.Surgeon removed the cap and inserted it again.
Additional Manufacturer Narrative
Method: risk assessment; result: no lot # was provided, so a manufacturing record review could not be performed.Product is not returned for inspection.Conclusion: the most plausible root cause of the event is cross threading of the blocker and tulip and application of force during final tightening.
Event or Problem Description
It was reported that; screw tulip splayed open while blocker was being final tightened with a standard torque wrench.The delay was one minute.Surgeon removed the cap and inserted it again.

• 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: 6567276
• Report Number: 3005525032-2017-00057
• Device Sequence Number: 13455896
• Product Code: MNH
• UDI-Device Identifier: 04546540598592
• UDI-Public: (01)04546540598592
• Combination Product (Y/N): N
• 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): 07/25/2017

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 Model Number: 482318545
• Device Catalogue Number: 482318545
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2017
• Supplement Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/15/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1