MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 35; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 48146535

Device Problems Break (1069); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems Dyspnea (1816); Fall (1848); Pain (1994); Injury (2348); Ambulation Difficulties (2544)

Event Date 05/16/2018

Event Type  Injury  

Event Description

It was reported that the rod broke in half and screws came out post-operatively.Patient reportedly had fall in (b)(6) of 2017 in which she tripped over a chair and fell on their knees.The patient was in pain, couldn't walk, trouble breathing and couldn't lift arm.The patient underwent revision surgery on (b)(6) 2018 to replace hardware.

Manufacturer Narrative

Method: surgical note review, nc/capa history review, labelling review, risk assessment result: the reported event was confirmed upon surgical note review.Products were not returned for evaluation and no lot# was provided therefore manufacturing records review and complaint history review could not be performed.Conclusion: the root cause of the reported event could not be determined conclusively but it is likely that the screws loosening may have been resulted due to fatigue caused by instability of construct post rod fracture.

Event Description

It was reported that the rod broke in half and screws came out post-operatively.Patient reportedly had fall in thanksgiving of 2017 in which she tripped over a chair and fell on their knees.The patient was in pain, couldn't walk, trouble breathing and couldn't lift arm.The patient underwent revision surgery on (b)(6) 2018 to replace hardware.

• Brand Name: XIA TITANIUM 4.5 POLYAXIAL SCREW DIAM 6.5 X 35
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8139682
• MDR Text Key: 129572183
• Report Number: 0009617544-2018-00291
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 04546540450258
• UDI-Public: 04546540450258
• Combination Product (y/n): N
• PMA/PMN Number: K121342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48146535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 175