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

Model Number	03805002
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient was initially implanted on (b)(6) 2016 for l3-l4.On (b)(6) 2016, extension was performed for th7.Upon follow up, on (b)(6) 2018, it was confirmed a rod dislodged from the rod to rod clamp connector.There was no plan for revision surgery.There are no reports of adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information was received of patient experiencing pain and subsequently undergoing revision surgery of (b)(6) 2018.Section were updated accordingly.Method: x-rays, device history review, complaint history review, risk assessment; result: the customer reported event was confirmed via communication with the sales rep and x- ray images provided.The device was discarded at the hospital and is unavailable for evaluation.Additionally, no lot number was provided, so a device history review could not be performed.Conclusion: the x-ray shows that both rods slipped out of the rod to rod connectors.The rod length does not seem adequate in the x ray provided as there is not enough overhang to properly seat the rod into the connector and tighten down with the blockers.Additional factors that could have contributed to the event include patient post op activity, inadequate tightening of the connector blockers, excessive force applied, and patient factors.As the device was not returned for evaluation, a definite root cause cannot be determined.
Event or Problem Description
It was reported that a patient was initially implanted on (b)(6) 2016 for l3-l4.On (b)(6) 2016, extension was performed for th7.Upon follow up, on (b)(6) 2018, it was confirmed a rod dislodged from the rod to rod clamp connector.Revision was performed (b)(6) 2018 due to patient pain.

• Brand Name: XIA ROD TO ROD CLAMP - AXIAL
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; -; allendale NJ 07401
• MDR Report Key: 7328861
• Report Number: 3005525032-2018-00008
• Device Sequence Number: 10936086
• Product Code: NKB
• UDI-Device Identifier: 04546540147998
• UDI-Public: (01)04546540147998
• Combination Product (Y/N): N
• PMA/510(K) Number: K060361
• 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): 06/19/2018

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 03/09/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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