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

Model Number LS-N6MG6540

Device Problem Break (1069)

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

Event Date 02/02/2024

Event Type  Injury  

Event Description

On february 2nd, 2024, accelus was informed of a complaint for a linesider mis procedure.It was reported that during an initial posterior fusion, the tulip tabs broke at the incorrect location, intraoperatively leaving a portion of the extended tab in the patient.Based on the reported information provided, the surgeon did not use the proper tools provided by accelus, prescribed by the linesider surgical technique, to ensure that the tabs break in the correct sequence and location.The surgeon then finished the surgery by opening the incision site and aborting mis screw placement.The tabs and mis screws were removed and replaced with standard open screws.No adverse patient symptoms were reported as a result of the extended surgery.There was a 30 min delay to the procedure reported.

Manufacturer Narrative

Based on the information provided, the results of the investigation determined that the surgeon did not use of the appropriate tool to remove the mis upper tabs.Therefore, the root cause can be attributed to user error.(b)(6) (k) was reviewed to ensure that it addresses this issue and does not require any updates.The parts were not returned and no lot numbers were provided for the reported devices, therefore, a dhr review could not be performed.There is no evidence to suggest that the devices were nonconforming before use and as such no further escalation is required at this time.We will continue to monitor for similar complaints and emerging trends.

• Brand Name: LINESIDER SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens 33418
• Manufacturer Contact: lauren kamer ; integrity implants inc.; palm beach gardens 33418
• MDR Report Key: 18826687
• MDR Text Key: 336782924
• Report Number: 3012797630-2024-00004
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Model Number: LS-N6MG6540
• Device Catalogue Number: LS-N6MG6540
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 71 YR
• Patient Sex: Female