MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS VITALLIUM ROD 5.5 X 600 MM W/HEX; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	486613602
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the rod was broken post- operatively.Patient underwent revision surgery for rod breakage and possible non-union.
Additional Manufacturer Narrative
Method: risk assessment and visual inspection was performed.Result: radius vitallium rod main body fracture post-op was confirmed via visual inspection.No lot number was provided, so a manufacturing record review could not be performed.Conclusion: beach marks were observed on the rod fracture surfaces, which indicates that the rod fractured via fatigue; therefore, the root cause of the reported rod fracture is due to fatigue after its implantation about 4 years.
Event or Problem Description
It was reported that the rod was broken post- operatively.Patient underwent revision surgery for rod breakage and possible non-union.

• Brand Name: RADIUS VITALLIUM ROD 5.5 X 600 MM W/HEX
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8366832
• Report Number: 0009617544-2019-00015
• Device Sequence Number: 1620799
• Product Code: NKB
• UDI-Device Identifier: 04546540604859
• UDI-Public: 04546540604859
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K082608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 486613602
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 02/25/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1