MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC. LINESIDER NON-MOD STANDARD TULIP, DUAL LEAD NON-CANNULATED SHANK; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	LS-N6SG6550
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Fda recall number has not yet been assigned.Manufacturer recall designation is 3012797630-02022022-00006-r.
Event or Problem Description
On 27jan2022 accelus was informed of a post operative failure on a non-modular standard screw.The original procedure was performed on (b)(6) 2021.During a 6 week follow up visit it was confirmed by x-ray imaging that one of the tulips was dissociated from the screw shank.Accelus was advised that the screw head appears in imaging to have broken at the point where it attaches to the shaft (or tulip was dissociated from the screw) and this may be consistent with a potential weld failure though investigation is still underway.The patient is currently asymptomatic, at this time there are no plans to perform a revision surgery.The surgeon intends to monitor the patient.

• Brand Name: LINESIDER NON-MOD STANDARD TULIP, DUAL LEAD NON-CANNULATED SHANK
• 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: lauren kamer ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615293861
• MDR Report Key: 13559965
• Report Number: 3012797630-2022-00009
• Device Sequence Number: 4313101
• Product Code: NKB
• UDI-Device Identifier: 00818613022674
• UDI-Public: (01)00818613022674(10)02210147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K203367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/18/2022

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: LS-N6SG6550
• Device Catalogue Number: LS-N6SG6550
• Device Lot Number: 02210147
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: REFER TO H10
• Patient Sequence Number: 1
• Patient Sex: Unknown