MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC LINESIDER SPINAL SYSTEM DUAL LEAD SHANK- CANNULATED 6.5MM X 45MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number LS-SC7G6545

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer indicated that the product would not be returned to integrity implants for investigation as it had been discarded by the hospital.Because the device was discarded, the lot number of the device involved could not be determined.The reported event was unable to be confirmed due to limited information received from the customer.The device history records for all potential lot numbers were reviewed and no discrepancies relevant to the reported event were found.A review of the complaint history determined that no further action was required as no trends were identified.A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.However, investigation results concluded that the reported event was likely due to misuse of the system in a combination that has not been assessed or indicated as compatible by integrity implants.A safety notice was issued by medtronic warning against the use of the stealthstation surgical navigation and navlock tracker array with unapproved, non-medtronic, instruments in april 2017.Subsequently, fda issued a similar notice to health care providers in may 2017 recommending against the use of any surgical stereotaxic instruments that have not been cleared by the fda for use with the medtronic stealthstation surgical navigation and navlock tracker array.A summary of the investigation was sent to the complainant conveying proper surgical technique and use of the device.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Integrity implants will continue to monitor for trends.

Event Description

It was reported that the patient underwent an initial one-level transforaminal lumbar interbody fusion with posterior fixation.During the procedure, the surgeon utilized a surgical navigation system and experienced difficulties with placement of the screw shanks in the vertebrae.There was no failure or malfunction associated with the screw shanks; however, the difficulties with placing the implants using the navigation resulted in the inadvertent placement of the screw shanks into areas of the surrounding disc space.In an effort to correct the screw trajectories, three of the four screw shanks were removed and replaced several times, resulting in a surgical delay of approximately 30-45 minutes with no further harm to the patient.Subsequently, the patient underwent a revision procedure to reposition one of the screw shanks approximately two days later.No additional patient consequences were reported.

• Brand Name: LINESIDER SPINAL SYSTEM DUAL LEAD SHANK- CANNULATED 6.5MM X 45MM
• Type of Device: 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: 11156849
• MDR Text Key: 226549771
• Report Number: 3012797630-2021-00001
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2021

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
• Device Operator: Health Professional
• Device Model Number: LS-SC7G6545
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR