MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 35 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 482317535

Device Problems Break (1069); Entrapment of Device (1212); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 09/19/2017

Event Type  malfunction  

Event Description

It was reported that; when the screw was removed during surgery, the tulip head was stuck.Therefore, the screw was removed with kochel.Update (b)(6): when the surgeon was performed final tightening of screw, the anti torque key came off from the screw and the screw hole thread was broken.Therefore, the screw was removed.

Manufacturer Narrative

Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Visual inspection showed the threads were found to be deformed which can be indicative of blocker misalignment or cross threading.Conclusion: the plausible root cause of the event is determined to be use error- misalignment of the blocker and the tulip.

Event Description

It was reported that; when the screw was removed during surgery, the tulip head was stucked.Therefore, the screw was removed with kochel.Update 10/16/2017: when the surgeon was performed final tightening of screw, the anti torque key came off from the screw and the screw hole thread was broken.Therefore, the screw was removed.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 35 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6954567
• MDR Text Key: 90414014
• Report Number: 0009617544-2017-00378
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 04546540562333
• UDI-Public: (01)04546540562333
• Combination Product (y/n): N
• PMA/PMN Number: K113666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

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
• Device Operator: No Information
• Device Model Number: 482317535
• Device Catalogue Number: 482317535
• Device Lot Number: B67251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 09/19/2017
• Supplement Dates FDA Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1