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

Model Number 482317550

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/20/2021

Event Type  Injury  

Event Description

It was reported that the tulip disengaged from the xia 3 polyaxial screw at l5, approximately a few weeks post-operatively.Revision surgery has been performed.

Manufacturer Narrative

A visual inspection was performed.Tulip was confirmed to be disengaged from screw shank.Locking ring of tulip is deformed.Wear is observed on locking ring and on the anterior side of tulip, adjacent to the locking ring deformation.Screw shank bulb has a rod witness mark trending towards one side of the bulb.Wear is observed on the entire screw shank bulb and a section of the screw/driver star pattern interface.Deformation of the locking ring of the tulip and the shank bulb witness mark location both indicate that tulip may have been over angulated with respect to the shank during final tightening.Device history records were reviewed for the corresponding lot and no relevant issues were identified.Complaint history record review was performed for this lot, and no similar complaints were identified.It was reported that the patient was revised 3 months after initial surgery due to tulip disengagement.X-ray was reviewed which confirms tulip disengagement.Follow up with rep reveals that there were no complications during initial surgery.Screw hole was tapped with a 6.5 mm tap, not at a difficult angle.Patient denies falling and activity was normal.Bone quality was normal.It was reported that the patient felt the grinding of the screw immediately post op, which indicates the tulip disengaged immediately after the procedure and was not engaged for the next 3 months.Due to wear observed on the screw shank head and tulip base, a root cause could not be determined conclusively.Tulip over angulation with respect to shank most likely contributed to reported event, but cannot be confirmed due to wear.Excessive torque applied during final tightening may have also contributed to reported event, but cannot be confirmed due to wear.

Event Description

It was reported that the tulip disengaged from the xia 3 polyaxial screw at l5, approximately a few weeks post-operatively.Revision surgery has been performed.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW DIA 7.5 X 50 MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12940364
• MDR Text Key: 281837936
• Report Number: 0009617544-2021-00227
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540562364
• UDI-Public: 04546540562364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142381
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 482317550
• Device Catalogue Number: 482317550
• Device Lot Number: A91716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/08/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 02/04/2022
• Supplement Dates FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male