MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC LINESIDER SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	LS-TU7S5560
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Vertebral Fracture (4520); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On 12-jul-2024, accelus was made aware of an issue with an impant that a tulip came off a shank causing failure.It had separated.A revision surgery was needed due to pathology / fracture that occurred due to hardware failure from the first surgery and it is unknown the exact timing of that failure.The revision surgery took place approximately 7 weeks after the initial surgery (implant date: (b)(6) 2024, explant date: (b)(6) 2024).The rep reported, "i cannot answer if the patients was complaining.I do not know the answer.I do not know the outcome of the revision long term, but the information is that the revision was completed successfully but not sure if that was with accelus product or not." the failed product was removed.
Additional Manufacturer Narrative
Based on the information provided and the engineering analysis, the 2 tulips returned confirmed the reported failure as the tulips were returned separated from the shanks.The split rings were deformed, however, that does not determine the devices to be nonconforming as they were subject to conditions of use (7 weeks of use and removal) and no evidence was identified during the dhr review and complaint investigation to suggest that there were manufacturing issues.The complaint does not present a significant risk to patient safety or device effectiveness.No trend has been identified per the review conducted in this complaint and engineering analysis.No further escalation is required at this time.We will continue to track and trend.

• Brand Name: LINESIDER SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer (Section G): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• Manufacturer Contact: chris mckee ; 354 hiatt drive; palm beach gardens, FL 33418 ; 9014939467
• MDR Report Key: 19951030
• Report Number: 3012797630-2024-00010
• Device Sequence Number: 21057386
• Product Code: NKB
• UDI-Device Identifier: 00818613029055
• UDI-Public: (01)00818613029055(10)07230032
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LS-TU7S5560
• Device Catalogue Number: LS-TU7S5560
• Device Lot Number: 07230032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LS-TU7S5560, LOT: 12230019.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown