MAUDE Adverse Event Report: STRYKER SPINE-US XIA LP POLYAXIAL SCREW 6.5 X 55MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22

Catalog Number	03821655
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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
Method: visual inspection, product history review, complaint history review, nc/capa history review, labeling review, risk assessment.Result: the customer reported event of was confirmed via visual inspection.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 and suboptimal rod placement.Additionally, 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 not fully perpendicular with the screw when final tightening occurred and was at an angle inside the tulip.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The surgical technique calls for the rod to be perpendicular to the screw when being seated into the rod.Conclusion: the most likely root cause is the position of the rod caused additional torque to be applied to the screw which eventually caused the tulip to disengage.
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 LP POLYAXIAL SCREW 6.5 X 55MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7910827
• Report Number: 3005525032-2018-00059
• Device Sequence Number: 11159465
• Product Code: NKB
• UDI-Device Identifier: 04546540149268
• UDI-Public: 04546540149268
• 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: 03821655
• Device Lot Number: B23407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2018
• 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