MAUDE Adverse Event Report: SEASPINE ORTHOPEDICS CORPORATION MALIBU DLTA SCREW 7.5 DIA X 35 MM

Model Number	15-7535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Explanation for h3: device is currently being evaluated, however, findings are not yet available results pending outcome of investigation.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components postoperative fracture due to trauma, defects, or poor bone stock.
Event or Problem Description
On (b)(6) 2023, a 13-year old patient underwent spinal surgery for l5 spondylitis utilizing seaspine's malibu delta screws.The levels covered during surgery were l4 -s1.Sometime in (b)(6) 2024, the patient was getting into their bed when they felt something move.The next day, the patient went in to get an x-ray and it was determined the patient experienced a post-operative screw fracture.A revision surgery was performed on (b)(6) 2024.No patient injury was reported.
Additional Manufacturer Narrative
Investigation conclusion: the screw was visually inspected and it was confirmed that the screw shank component experienced a brittle fracture at the neck.The screw was dimensionally inspected and all critical mating features were found to be within specification with the exception of the dimension on the malibu housing dlta (15-4500-24) component.Also, the screw was functionally tested with a mating locking cap and it properly interfaced as intended.Two additional screws from the same lot were pulled from inventory.These screws were dimensionally inspected and all critical mating features were found to be within specification with the exception of the dimension on the malibu housing dlta (15-4500-24) component.Also, the screws were functionally tested with a mating locking cap and they properly interfaced as intended.The dimension on the malibu housing dlta (15-4500-24) component measuring undersized is unlikely to have contributed to the failure.It is possible that significant load experienced in-situ or post-op could have resulted in deformation which may have contributed to this feature measuring undersized.Additionally, the tolerance of this dimension has since been increased on the change to 15-4500-20 rev.F.Therefore, this feature is conforming per the updated specification.The neck diameter of the screw, which was the location of the failure mode, was dimensionally inspected and it was found to be within specification.Significant load or torsional load post-op likely contributed to the brittle fracture at the neck of the screw shank component, however, that cannot be confirmed.Review of labeling: possible adverse events bending, disassembly, or fracture of implant and components postoperative fracture due to trauma, defects, or poor bone stock.
Event or Problem Description
On (b)(6) 2023, a 13-year old patient underwent spinal surgery for l5 spondylitis utilizing seaspine's malibu delta screws.The levels covered during surgery were l4 -s1.Sometime in (b)(6) 2024, the patient was getting into their bed when they felt something move.The next day, the patient went in to get an x-ray and it was determined the patient experienced a post-operative screw fracture.A revision surgery was performed on (b)(6) 2024.No patient injury was reported.

• Brand Name: MALIBU DLTA SCREW 7.5 DIA X 35 MM
• 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: danielle nelson-archer ; 5770 armada dr.; carlsbad, CA 92008
• MDR Report Key: 20248546
• Report Number: 3012120772-2024-00067
• Device Sequence Number: 15276801
• Product Code: NKB
• UDI-Device Identifier: 10889981003487
• UDI-Public: 10889981003487
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232566
• 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): 01/15/2024

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: 15-7535
• Device Catalogue Number: 15-7535
• Device Lot Number: MW06858A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 01/14/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2012
• 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 Age: 13 YR
• Patient Sex: Unknown