MAUDE Adverse Event Report: STRYKER SPINE-US XIA 3 TITANIUM RAD ROD DIAM 6MM L 110MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48238110
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after a lumbar surgery, both rods pulled out of the tulip and migrated south.The patient is anticipated to undergo revision surgery.Revision has not yet been scheduled.
Event or Problem Description
It was reported that after a lumbar surgery, both rods pulled out of the tulip and migrated south.The patient is anticipated to undergo revision surgery.Revision has not yet been scheduled.
Additional Manufacturer Narrative
The customer reported event was confirmed via x rays.The device is unavailable as they were implanted.The lot # was not provided therefore, device inspection, device history review, and complaint history review could not be completed.Review of the provided x rays indicate that the rod was not long enough to properly seat into the screw tulip.The rod was only about half way seated into the tulip head.Not having sufficient rod overhang could cause the rod to slip out over time as the blocker will not have full contact with the rod to hold it down.The most likely root cause is insufficient rod length.

• Brand Name: XIA 3 TITANIUM RAD ROD DIAM 6MM L 110MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7674378
• Report Number: 3005525032-2018-00047
• Device Sequence Number: 19184794
• Product Code: NKB
• UDI-Device Identifier: 07613154939732
• UDI-Public: 07613154939732
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2018

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 Catalogue Number: 48238110
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 10/16/2018
• 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