MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL LINESIDER NON-MOD MIS TULIP, DUAL LEAD CANNULATED SHANK; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	LS-N6MG7545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2022 accelus was informed of a failure on a non-modular mis tulip screw (part: ls-n6mg7545).The surgeon at the specialty hospital of shreveport was performing a two level alif and fixation procedure on (b)(6) 2022.The failure was noted by the surgeon's pa while they were reviewing postop films prior to discharging the patient.Further discussion with the surgeon confirmed that the failure occurred intraoperatively and went unnoticed at the time of the procedure.Film images confirmed a screw head separation at the l4 segment.The patient was not discharged, and a revision surgery was performed on (b)(6) 2022 to remove and replace the impacted screw.The patient is reportedly doing fine with no further issues or complications.
Additional Manufacturer Narrative
At this time integrity implants has not received a recall report number from the fda.The company internal report reference number is 3012797630-02022022-00006-r.

• Brand Name: LINESIDER NON-MOD MIS TULIP, DUAL LEAD CANNULATED SHANK
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL; 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: rod atkins ; 354 hiatt drive; palm beach gardens, FL 33418 ; 5615064996
• MDR Report Key: 13656845
• Report Number: 3012797630-2022-00010
• Device Sequence Number: 13929667
• Product Code: NKB
• UDI-Device Identifier: 00818613026542
• UDI-Public: (01)00818613026542(10)02210104
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K203367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 03/02/2022

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-N6MG7545
• Device Catalogue Number: LS-N6MG7545
• Device Lot Number: 02210104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2022
• Initial Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2021
• 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: Required Intervention
• Patient Sex: Unknown