MAUDE Adverse Event Report: STRYKER SPINE-US RADIUS 5.5 X 120 RAD ROD; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	486615020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted in the patient.
Event or Problem Description
During routine follow up after surgery it was found that the patient had broken rod, connector, and tulip on screw came off.This record captures the reported fracture of a radius rod.
Additional Manufacturer Narrative
The reported issue of radius rad rod fracture was confirmed upon review of provided x-ray images.The initial procedure was done on (b)(6) 2021.Revision surgery is not planned at the time.As the device remains implanted in the patient, further visual and functional evaluation could not be performed.Manufacturing and complaint history could not be reviewed as the corresponding lot number was not provided.However, complaint history records were reviewed for the corresponding catalog number, and no similar complaints were identified.Review of the x-rays indicate that the screw was likely over angulated, and the rod was not placed horizontally below the blocker, inside the tulip head.However, a conclusive cause of the reported event could not be determined as the device remains implanted.Potential causes include: over angulation of screw tulip, unstable/ overtightened construct leading to tulip disengagement, fracture of rod and connector, etc.H3 other text : device remains implanted in the patient.
Event or Problem Description
During routine follow up, it was found that the patient experienced rod fracture, connector fracture, and screw tulip disengagement post-operatively.This record captures the reported fracture of a radius rod.

• Brand Name: RADIUS 5.5 X 120 RAD ROD
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11886435
• Report Number: 0009617544-2021-00099
• Device Sequence Number: 3685092
• Product Code: NKB
• UDI-Device Identifier: 07613154515011
• UDI-Public: 07613154515011
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K113666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 486615020
• Device Catalogue Number: 486615020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR