MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION CORAL MIS SOLID POLYAXIAL SCREW

Model Number	18-12-6550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023 a patient underwent spinal surgery consisting of seaspine's coral and malibu posterior fixation systems.An mri was performed an unknown time later after the patient reported pain.The 18-12-6550 solid polyaxial screw, 6.50mm x 50mm was observed to have fractured.A revision surgery was performed on (b)(6) 2024 and two 10-17-0001 locking screw assemblies were observed to be loose as well.It was not possible to remove the entire broken screw, so the surgeon left the embedded piece in the patient and inserted a new screw at a different trajectory.The screw, screw assemblies, and a 12-1040 precontoured rod, 5.5 x 40mm were explanted.
Additional Manufacturer Narrative
No evaluation can be provided as the product has not been received for investigation.No definitive root cause could be established.Possible adverse events 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 postoperative fracture due to trauma, defects, or poor bone stock.
Additional Manufacturer Narrative
The 18-12-6550 solid polyaxial screw, 6.50mm x 50mm was returned and evaluated by the quality and product engineers.The screw shank fracture had a substantial vertical segment on one side of the cylinder.This indicates that one side of the thread experienced more stress after insertion into the pedicle.One locking cap showed evidence that final tightening may have not been achieved.If this occurred and the rod was able to slip in a medial/lateral rotation, more force would be applied perpendicular to the screw shank.Over time, the additional stress could have contributed to the fracture.Possible adverse events: 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, discomfort, or abnormal sensations due to the presence of the device postoperative fracture due to trauma, defects, or poor bone stock.
Event or Problem Description
On (b)(6) 2023, a patient underwent spinal surgery consisting of seaspine's coral and malibu posterior fixation systems.An mri was performed an unknown time later after the patient reported pain.The 18-12-6550 solid polyaxial screw, 6.50mm x 50mm was observed to have fractured.A revision surgery was performed on (b)(6) 2024 and two 10-17-0001 locking screw assemblies were observed to be loose as well.It was not possible to remove the entire broken screw, so the surgeon left the embedded piece in the patient and inserted a new screw at a different trajectory.The screw, screw assemblies, and a 12-1040 precontoured rod, 5.5 x 40mm were explanted.

• Brand Name: CORAL MIS SOLID POLYAXIAL SCREW
• Common Device Name: SCREW
• 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: amanda fonseca ; 5770 armada dr.; carlsbad, CA 92008 ; 7602165655
• MDR Report Key: 19441571
• Report Number: 3012120772-2024-00025
• Device Sequence Number: 18264470
• Product Code: NKB
• UDI-Device Identifier: 10889981016012
• UDI-Public: 10889981016012
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K120047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 18-12-6550
• Device Catalogue Number: 18-12-6550
• Device Lot Number: BR37942N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 10-17-0001 LOCKING SCREW ASSEMBLY.; 12-1040 PRECONTOURED ROD, 5.5 X 40MM.; 12-1040 PRECONTOURED ROD, 5.5 X 40MM.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown