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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 0009617544-2021-00227
• Device Sequence Number: 4955911
• Product Code: NKB
• UDI-Device Identifier: 04546540562364
• UDI-Public: 04546540562364
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K142381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male