MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC. LINESIDER SPINAL SYSTEM, SET SCREW T25 5.5-6.0 TULIP; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number LSSS25560

Device Problem Migration (4003)

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

Event Date 09/15/2022

Event Type  Injury  

Manufacturer Narrative

While the set screw was returned to integrity implants, the lot number on the returned device was illegible due to damage.

Event Description

On (b)(6) 2022, accelus was made aware of a complaint regarding a linesider spinal system set screw (part: lsss25560, lot: unknown).It was reported that the patient underwent a l4-l5 tlif procedure with pedicle screw fixation from l3-l5 on (b)(6) 2022.Post procedure the patient reported that they had a traumatic fall in the bathtub.Upon examination by x-ray it was noted that the right l5 set screw was dissociated and that the distal portion of the rod was elevated.As a result, the surgeon opted to perform a revision surgery to replace the dissociated set screw and examine the construct.The revision surgery was performed on (b)(6) 2022.During the revision procedure the surgeon noted that the l4 and l5 pedicle screws were still adequately in place.The surgeon was able to remove and replace the dissociated l5 set screw through a small incision.No additional patient harm was reported.It was reported by the surgeon that they did not believe the linesider spinal system had failed.He believed that the failure occurred due to the traumatic fall that patient had and patient non-compliance with the surgeon's instructions.

• Brand Name: LINESIDER SPINAL SYSTEM, SET SCREW T25 5.5-6.0 TULIP
• 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: 15611471
• MDR Text Key: 301810121
• Report Number: 3012797630-2022-00018
• 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
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSSS25560
• Device Catalogue Number: LSSS25560
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2022
• 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: 60 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic