MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ATOLL; PRE-BENT OCCIPITAL ROD (110 DEGREES -170MM)

Model Number	16-33-0170
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Neck Pain (2433); Limb Pain (4836)
Type of Reportable Event	Malfunction
Event or Problem Description
Orthofix was made aware on 17 mar 2026 that a patient underwent a spinal surgery consisting of the atoll and sierra oct systems.The index surgery was performed on (b)(6) 2021 involving a posterior construct spanning from occipital to t2.The patient reportedly remained hospitalized for approximately one week postoperatively due to complications and pain.There were then follow-ups conducted for approximately 3 months, after which care was discontinued at the surgeon's discretion.The patient reported a persistent audible noise post-implantation.The patient was then seen on (b)(6) 2022 by a different surgeon than the one that performed the index surgery.At this follow-up, the patient reported pain in the right side of the neck, shoulder, and arm.The patient was diagnosed with cervical pseudarthrosis at c1c2, a fractured rod breakage at c1c2 on the left, screw loosening in the occipital plate, bilateral c1, bilateral c2, lateral positioning of t2 screw on the right, and lateral mass screw loosening at c3, c4 and c5.A revision surgery was then conducted on (b)(6) 2022.Post-operatively, the patient reported ongoing pain at t2-t3, nerve-related symptoms including scapular and shoulder issues, and the potential need for additional surgical intervention.The part number of the rod that fractured was 16-33-0170 pre-bent occipital rod (110 degrees -170mm).The reporter did not specify the part numbers of the screws which loosened.This report is being submitted to document the 16-33-0170 pre-bent occipital rod fracture.
Additional Manufacturer Narrative
Although the reporter stated that the explanted hardware had been retained, no associated complaint products have been returned for evaluation.Additionally, no postoperative imaging confirming the reported malfunctions were provided.Due to the absence of the returned devices, the specific root cause cannot be conclusively determined.Review of labeling: possible adverse events.Like other spinal system implants, the following adverse events are possible.This list is not exhaustive: delayed union or nonunion (pseudarthrosis).Bending, disassembly, or fracture of implant and components.Loosening of spinal fixation implants may occur due to inadequate initial fixation, latent infection, and/or premature loading, possibly resulting in bone erosion, migration, or pain.Pain, discomfort, or abnormal sensations due to the presence of the device.

• Brand Name: ATOLL
• Common Device Name: PRE-BENT OCCIPITAL ROD (110 DEGREES -170MM)
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer (Section G): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• Manufacturer Contact: robin quiusky ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 24849124
• Report Number: 3012120772-2026-00019
• Device Sequence Number: 8936418
• Product Code: MNI
• UDI-Device Identifier: 10889981034498
• UDI-Public: 10889981034498
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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 Model Number: 16-33-0170
• Device Catalogue Number: 16-33-0170
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 16-17-0000 LOCKING SCREW ASSEMBLY; 16-30-3141 MEDIUM OCCIPITAL PLATE; 50-0035 CLOSED LATERAL CONNECTOR, 3.5 ROD; 50-1000 SIERRA LOCKING CAP; 50-2012 CONTOURED CROSSBAR, MEDIUM, 3.5 ROD; 50-2013 CONTOURED CROSSBAR, LARGE, 3.5 ROD
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown