MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482318545
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that when the rod was inserted into the screw head with a persuader, the screw head came off the screw shaft.The screw and rod were removed and replaced with new ones.There were no broken fragments.There was a surgical delay of hone hour and no adverse consequences to the patient.
Event or Problem Description
It was reported that when the rod was inserted into the screw head with a persuader, the screw head came off the screw shaft.The screw and rod were removed and replaced with new ones.There were no broken fragments.There was a surgical delay of one hour and no adverse consequences to the patient.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment.Result: the customer reported event was confirmed via visual inspection.There were no broken fragments left in patient.The screw was returned in 2 pieces.There was deformation onside of the tulip locking ring and deformation on the screw shank head, indicative of the tulip being over angled in one direction.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.As a new harm " of 60 minutes surgical delay" was identified during this investigation, non-conformance was opened for this complaint.Conclusion: the most likely root cause is the tulip was over angled while persuading as seen by the deformation on the screw.It is also unknown if the surgeon applied cantilever force that would cause the screw to become over angled and disengaged.

• Brand Name: XIA 3 TITANIUM POLYAXIAL SCREW 8.5 X 45MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7898479
• Report Number: 3004024955-2018-00045
• Device Sequence Number: 1683626
• Product Code: NKB
• UDI-Device Identifier: 04546540598592
• UDI-Public: 04546540598592
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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: 482318545
• Device Lot Number: B67666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 12/21/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 69