MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION TI LOCKING CAP ASM. 4.5MM SMALL STATURE; SCREW

Model Number	76-0030
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the returned parts is ongoing.The following reports are also related: 3012120772-2024-00078, 3012120772-2024-00079, 3012120772-2024-00080, 3012120772-2024-00081, 3012120772-2024-00082.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery utilizing seaspine's daytona small stature spinal system.During the procedure the surgeon had issues with the locking caps threading onto the screws, resulting in a 30-45 minute surgical delay.No patient injury was reported.13 units of part 79-0002 and 3 units of part 76-0030 were returned.See related reports.This report is for 3 of 3 units of part 76-0030, lot md15297d.
Additional Manufacturer Narrative
The locking cap was functionally tested with mating parts and found to not mate properly.When advancing the locking cap, the locking cap component became stuck at the proximal end of the screw housing and was not able to advance further.Upon disassembly it was noted that the cap had significant damage to the threads, which is indicative of cross-threading.A health hazard evaluation was initiated to analyze this failure.It was determined that although there may be information to suggest a potential non-conformance with pn 76-0030, the non-conformance presents a negligible risk to patients as the locking cap would be unable to appropriately fit with the mating parts.This would result with the locking caps being replaced intra-operatively.Pn 76-0030 is no longer being manufactured, therefore no further action will be taken at this time.The following reports are also related: 3012120772-2024-00078, 3012120772-2024-00079, 3012120772-2024-00080, 3012120772-2024-00081, 3012120772-2024-00082.Review of labeling: possible adverse events: bending, disassembly, or fracture of implant and components.
Event or Problem Description
On (b)(6) 2024, a patient underwent spinal surgery utilizing seaspine's daytona small stature spinal system.During the procedure the surgeon had issues with the locking caps threading onto the screws, resulting in a 30-45 minute surgical delay.No patient injury was reported.13 units of part 79-0002 and 3 units of part 76-0030 were returned.See related reports.This report is for 3 of 3 units of part 76-0030, lot md15297d.

• Brand Name: TI LOCKING CAP ASM. 4.5MM SMALL STATURE
• 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: 20130657
• Report Number: 3012120772-2024-00083
• Device Sequence Number: 3226697
• Product Code: NKB
• UDI-Device Identifier: 10889981130619
• UDI-Public: 10889981130619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/26/2024

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: 76-0030
• Device Catalogue Number: 76-0030
• Device Lot Number: MD15297D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown