MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION COCR LOCKING CAP 4.5MM, SMALL STATURE, T25, BT; SCREW

Model Number	79-0002
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: 3012120772-2024-00079, 3012120772-2024-00080, 3012120772-2024-00081, 3012120772-2024-00082, 3012120772-2024-00083.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 8 of 8 units of part 79-0002, lot mm1003065e.
Additional Manufacturer Narrative
The locking cap was functionally tested with mating parts and found to not mate properly.The set screw component was unable to engage with the threads of the mating housings.Upon disassembly it was noted that the locking cap had significant damage to the threads, a nonconforming minor diameter and thread form, as well as damage at the higbee cut feature at the lead-in thread.This failure was analyzed under a health hazard evaluation and found the observed non-conformances represented a moderate risk of adverse health consequences.A field action was initiated to recall the affected lots of pn 79-0002.Refer to report of corrections and removal number 3012120772/11082024/r0001.The following reports are also related: 3012120772-2024-00079, 3012120772-2024-00080, 3012120772-2024-00081, 3012120772-2024-00082, 3012120772-2024-00083.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 8 of 8 units of part 79-0002, lot mm1003065e.

• Brand Name: COCR LOCKING CAP 4.5MM, SMALL STATURE, T25, BT
• 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: 20130637
• Report Number: 3012120772-2024-00075
• Device Sequence Number: 7483234
• Product Code: NKB
• UDI-Device Identifier: 10889981185640
• UDI-Public: 10889981185640
• 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
• Remedial Action: Recall
• 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: 79-0002
• Device Catalogue Number: 79-0002
• Device Lot Number: MM1003065E
• 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: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3012120772/11082024/R000
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown