MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION SIERRA SYSTEM; OCCIPITAL ROD, 90 DEGREES

Model Number	50-6290
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 12 mar 2021, seaspine was alerted that a rod used in the construct had broken in the postoperative period, and the patient went to the emergency room for treatment.No explants have been made available for examination at this time, as the device remains in situ.X- ray images indicate there was no change in the patient's condition following discovery of the damage to the construct, and revision surgery has not yet been scheduled.Communication with the reporter indicates the cause of the rod fracture may be related to stress put on the construct.The surgeon continues to monitor the patient for any indication necessitating additional treatment.Review of labeling: possible adverse events: -bending, disassembly or fracture of implant and components.
Event or Problem Description
The patient underwent spinal surgery consisting of products from seaspine's sierra system on (b)(6) 2020.On 12 mar 2021, seaspine was alerted that a rod used in the construct had broken in the postoperative period, and the patient went to the emergency room for treatment.X-ray images taken at this time did not indicate a change in the patient's condition, and the surgeon elected to postpone revision surgery.

• Brand Name: SIERRA SYSTEM
• Common Device Name: OCCIPITAL ROD, 90 DEGREES
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11642493
• Report Number: 3012120772-2021-00029
• Device Sequence Number: 3909613
• Product Code: KWP
• UDI-Device Identifier: 10889981043247
• UDI-Public: 10889981043247
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/09/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 50-6290
• Device Catalogue Number: 50-6290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/09/2021
• 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: Hospitalization; Other