MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482318570
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after insertion of the right side nail with blocker, screw pull out was confirmed in image examination.The screw has been removed and replaced.When the left side nail and screw were placed, it also pulled out during compression; the screw was removed and replaced by another, which had the head locked.The doctor removed the screw and chose not to put another.It was further reported that one of the screws did pull out of the head and after pullout verified, it was noticed that the ring on the inside of the screw had broken without large loose fragments.The surgical incision was washed.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
The customer reported event was confirmed via visual inspection.It was reported that the tulip disengaged while final tightening with the torque wrench and anti-torque key.The screw was returned in 2 pieces as the tulip was disengaged from the screw shank.The bottom of the tulip was deformed heavily on one side, indicating that the tulip head was over angulated in one direction.The damage on the screw shows that the tulip was over angulated until it eventually disengaged.Rod divot on the screw shank head indicates that the rod was perpendicular with the screw when final tightening occurred.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The plausible root cause of the event include excess torsional force, incorrect alignment, insufficient rod persuasion, or cantilever force applied to the tulip causing it to disengage from that side.
Event or Problem Description
It was reported that after insertion of the right side nail with blocker, screw pull out was confirmed in image examination.The screw has been removed and replaced.When the left side nail and screw were placed, it also pulled out during compression; the screw was removed and replaced by another, which had the head locked.The doctor removed the screw and chose not to put another.It was further reported that one of the screws did pull out of the head and after pullout verified, it was noticed that the ring on the inside of the screw had broken without large loose fragments.The surgical incision was washed.There are no reports of adverse consequences to the patient.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 70MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7910838
• Report Number: 3005525032-2018-00060
• Device Sequence Number: 11183348
• Product Code: NKB
• UDI-Device Identifier: 04546540598646
• UDI-Public: 04546540598646
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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: 482318570
• Device Lot Number: B77091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1