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

Model Number	76-0030
Medical Device Problem Code	Expulsion (2933)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Seaspine was made aware of this event on 3 may 2021.The locking cap has not been returned for evaluation, thus the root cause of the customer's experience has not been determined.Two of the torque handles used in the surgery were returned for evaluation.It was discovered that the torque handles were not within specification.It is possibles the instruments received for evaluation may have contributed to the event, but the precise cause cannot be established at this time.Review of labeling: 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.
Event or Problem Description
In (b)(6) of 2020, a (b)(6) girl underwent t2-l2 psif spinal surgery with seaspine's daytona small stature spinal system, jazz sublaminar bands, and small stature cross connectors.In a 2 week postoperative follow up, no complications were noted, however in the 3 month postoperative follow up, the surgeon noticed a disengagement of the l2 right pedicle screw cap, and recommended revision surgery.No additional details regarding the patient's condition or treatment plan have been communicated to seaspine.

• Brand Name: DAYTONA SMALL STATURE SPINAL SYSTEM
• Common Device Name: TI LOCKING CAP ASM. 4.5MM SMALL STATURE
• Manufacturer (Section D): SEASPINE ORTHOPEDICS CORPORATION; 5770 armada drive; carlsbad CA 92008
• MDR Report Key: 11926356
• Report Number: 3012120772-2021-00046
• Device Sequence Number: 14248572
• Product Code: NKB
• UDI-Device Identifier: 10889981130619
• UDI-Public: 10889981130619
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K200381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 06/02/2021

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: 76-0030
• Device Catalogue Number: 76-0030
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 11 YR
• Patient Weight: 48