MAUDE Adverse Event Report: STRYKER SPINE-US XIA ROD TO ROD CLAMP - AXIAL; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22

Model Number	03805002
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	03/08/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient presented increasing back pain at 1 year out meeting.X-rays showed that both rods were dislodged from the axial connectors at the l1 level.Revision surgery has been scheduled for the patient.
Additional Manufacturer Narrative
Lot #: 14a084.The reported event was confirmed via x-rays and visual inspection.It was reported that the rods disengaged from the connectors one year after surgery.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.Per device inspection, the opening was heavily deformed indicating that the rod was pushed down onto the bottom of the opening, deforming the connector.The set screws were examined.It was found that the set screws had heavy rod indentations on the bottom, indicating that excess force was applied to the set screw.The bottom threading of the set screws were also found to be deformed, most likely from excessive force being applied and pushing the connector against the rod.Inspection of the device indicates that excessive force was applied to the set screw, which pushed against the rod, which in turn pushed against the connector opening, deforming both the set screw and the connector itself.This caused instability in the connector as the set screw and connector are not properly securing the rod in place due to the deformation.Over the course of the year it was implanted, the rod worked it's way out of the deformed connector, most likely due to the patient's movement and eventually disengaged completely.The most likely root cause was excessive force applied during set screw tightening.
Event or Problem Description
It was reported that a patient presented increasing back pain at 1 year out meeting.X-rays showed that both rods were dislodged from the axial connectors at the l1 level.Revision surgery has been scheduled for the patient.

• Brand Name: XIA ROD TO ROD CLAMP - AXIAL
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM22
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7390661
• Report Number: 3005525032-2018-00022
• Device Sequence Number: 16456976
• Product Code: NKB
• UDI-Device Identifier: 04546540147998
• UDI-Public: (01)04546540147998
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/07/2018

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: No Information
• Device Model Number: 03805002
• Device Catalogue Number: 03805002
• Device Lot Number: 14A084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 102