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

Model Number	481322120
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	06/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an l2-s1 fusion, the rod dislodged from the l2 screws bilaterally resulting in the patient's second revision surgery.The procedure was completed successfully by repositioning the cage with new rods and blockers.Adverse reactions to the patient included revision surgery as it required medical intervention.
Additional Manufacturer Narrative
Method: risk assessment.Results: the event was confirmed via correspondence with a sales representative.Visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.Conclusion: it was reported that during final tightening the surgeon most likely passed 8 nm and final tightened the construct to approximately 10 nm.The surgical technique notes that during final tightening, 8 nm must not be exceeded.If the toque applied to the construct exceeds 8 nm this may result in compromised construct may require a revision surgery.The plausible root cause of the reported event is most likely excessive torque applied to tighten the construct.
Event or Problem Description
It was reported that after an l2-s1 fusion, the rod dislodged from the l2 screws bilaterally resulting in the patient's second revision surgery.The procedure was completed successfully by repositioning the cage with new rods and blockers.Adverse reactions to the patient included revision surgery as it required medical intervention.

• Brand Name: XIA 4.5 X 120 VITALLIUM 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: 7643349
• Report Number: 0009617544-2018-00157
• Device Sequence Number: 152410
• Product Code: NKB
• UDI-Device Identifier: 07613327002669
• UDI-Public: (01)07613327002669
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K092605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2018

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: 481322120
• Device Catalogue Number: 481322120
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 09/23/2018
• 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: 59 YR