MAUDE Adverse Event Report: STRYKER SPINE-US XIA 4.5 X 120 TITANIUM PREBENT AND PRECUT ROD W/OUT HEX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	481321120
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that post-op x-ray shows rod had pulled out of top screw.No adverse consequences to the patient was reported.No revision surgery has been scheduled.
Event or Problem Description
It was reported that post-op x-ray shows rod had pulled out of top screw.No adverse consequences to the patient was reported.No revision surgery has been scheduled.
Additional Manufacturer Narrative
Method: labelling review and risk assessment.Visual, dimensional, functional and materials analysis could not be performed as the device remains implanted.Manufacturing record review and complaint history review could not be performed as lot number was not provided.It was confirmed via x-ray that two rods migrated out of the top screw two weeks after the implantation.Both implants remain implanted.It was reported there were no complications during the original surgery.A torque wrench was used to final tighten, the starting arrows on the torque wrench were aligned, and anti-torque key was used.Patient¿s post op activity level is unknown, no patient's fall was reported, and patient did not fuse.The plausible root cause of the reported event is most likely user error.However, this cannot be confirmed conclusively without device evaluation.Surgical technique: the rod should be cut to the appropriate length with approximately 4mm of rod overhanging the screw.Based on the x-rays provided, the rods on the top screw do not overhang but are almost in alignment with both screws.Short rod placed in construct may cause the rod to pull out of tulip post-op.Additionally, short rod placement may have led to rod slipping out of the screws.Device remains implanted.

• Brand Name: XIA 4.5 X 120 TITANIUM PREBENT AND PRECUT ROD W/OUT HEX
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8493178
• Report Number: 0009617544-2019-00039
• Device Sequence Number: 1884045
• Product Code: NKB
• UDI-Device Identifier: 07613327003321
• UDI-Public: 07613327003321
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K092605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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: Health Professional
• Device Catalogue Number: 481321120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1