MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION ATOLL CERVICO-THORACIC SYSTEM; 3.5MM X 14MM POLY SCREW ASSM

Model Number	16-12-3514
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned 16-12-3514 3.5mm x 14mm polyaxial screw confirmed the shank sheared off around the 2nd full turn of the exposed thread; the failure occurred horizontally through the cylinder.None of the other returned screw assembly components were observed to be damaged.The information provided and inspection of the returned screw suggest excessive force was likely placed on the instrumentation and screw at the time of insertion due to resistance from the patient's hard bone, resulting in the fracture observed.Review of labeling: possible adverse events- bending, disassembly or fracture of implant and components.
Event or Problem Description
A patient underwent spinal surgery on (b)(6) 2021 consisting of seaspine's atoll pedicle fixation system.It was reported that the patient had very hard bone and a screw fractured upon insertion into the lateral mass.The surgeon elected to leave a portion of the screw in the patient.Additionally, there was no patient harm or injury and no indication necessitating medical or surgical intervention.

• Brand Name: ATOLL CERVICO-THORACIC SYSTEM
• Common Device Name: 3.5MM X 14MM POLY SCREW ASSM
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada dr.; carlsbad CA 92008
• MDR Report Key: 11822235
• Report Number: 3012120772-2021-00042
• Device Sequence Number: 13724529
• Product Code: KWP
• UDI-Device Identifier: 10889981052348
• UDI-Public: 10889981052348
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083073
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/13/2021

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: Health Professional
• Device Model Number: 16-12-3514
• Device Catalogue Number: 16-12-3514
• Device Lot Number: BR38067R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1