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
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Dyspnea (1816); Fall (1848); Pain (1994); Injury (2348); Ambulation or Postural Difficulties (2544)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rod broke in half and screws came out post-operatively.Patient reportedly had fall in (b)(6) 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.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8139738
• Report Number: 0009617544-2018-00292
• Device Sequence Number: 11151270
• Product Code: NKB
• UDI-Device Identifier: 04546540450258
• UDI-Public: 04546540450258
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K121342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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: 48146535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/25/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 02/20/2019
• 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: Other; Required Intervention
• Patient Age: 65 YR
• Patient Weight: 175