MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC, PALM BEACH GARDENS, FL LINESIDER NON-MOD STANDARD TULIP, 7.5 X 45MM DUAL LEAD SHANK; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	LS-N6SG7545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 08-dec-2021 accelus was informed of a post-operative failure on a non-modular standard screw.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 original procedure was a 2 level tlif and fixation procedure and took place on (b)(6) 2021.Currently there are no plans to perform a revision surgery as the patient is doing well and healing as expected.No patient harm was reported.
Additional Manufacturer Narrative
At the time of the initial mdr filing integrity implants was reviewing all data to determine if a recall was required.Subsequent review determined that a recall action was required.This mdr follow up reflects this change.The recall was post marked on 02/03/2022.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.
Event or Problem Description
On 08dec2021 accelus was informed of a post-operative failure on a non-modular standard screw.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 original procedure was a 2 level tlif and fixation procedure and took place on (b)(6) 2021.Currently there are no plans to perform a revision surgery as the patient is doing well and healing as expected.No patient harm was reported.

• Brand Name: LINESIDER NON-MOD STANDARD TULIP, 7.5 X 45MM DUAL LEAD 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: 13196810
• Report Number: 3012797630-2022-00001
• Device Sequence Number: 4405245
• Product Code: NKB
• UDI-Device Identifier: 00818613022735
• UDI-Public: (01)00818613022735(10)02210152
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup
• Report Date (Section B): 03/03/2022

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-N6SG7545
• Device Catalogue Number: LS-N6SG7545
• Device Lot Number: 02210152
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2021
• 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
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic