MAUDE Adverse Event Report: STRYKER SPINE-US XIA TITANIUM 4.5 VITALIUM ROD 4.5 X 600 MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	48132601
Medical Device Problem Code	Fracture (1260)
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) 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.
Additional Manufacturer Narrative
Method: surgical notes review, x-ray image review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed upon review of surgical notes and x-ray image.Products were not returned for evaluation and no lot# was provided therefore manufacturing records review and complaint history review could not be performed.Patient was reported to have had a fall in thanksgiving of 2017 in which she tripped over a chair and fell on knees.Conclusion: the root cause of the reported event could not be determined conclusively but it is likely that the patient fall (a few months ago) may have contributed to the event - perhaps a crack in the rod at the time of fall which may have lead to fracture due to fatigue over time.
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 VITALIUM ROD 4.5 X 600 MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8139735
• Report Number: 0009617544-2018-00290
• Device Sequence Number: 194913
• Product Code: NKB
• UDI-Device Identifier: 04546540539663
• UDI-Public: 04546540539663
• 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: Health Professional
• Device Catalogue Number: 48132601
• 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