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

Model Number	LS-N6SA7550
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint lot has been recalled for a separate issue under manufacturer recall number 3012797630-02022022-00006-r.
Event or Problem Description
On 03feb22 accelus was informed of a complaint on a linesider non-modular standard screw.It was originally reported by the rep that an intraoperative screw head separation had occurred during the procedure.At the time, this was all the information that was available.New information was received on 11mar22.Per the complaint entry form received on 11mar22, the reported weld failure occurred during a revision procedure.The initial surgery was a 4 level plif and fixation procedure that took place on (b)(6) 2021.During a postoperative follow up visit it was noted that one of cephalad screws was loosening, as a result, the surgeon opted to revise the procedure.The revision procedure took place on (b)(6) 2022.It was noted during the revision procedure that one of the caudal screws had a separated tulip head.It is unknown if this separation occurred postoperatively or during the revision procedure.The procedure was completed by removing and replacing the loose cephalad screw and the separated caudal screw.The reported weld failure resulted in a 10 minute delay to the revision procedure.No additional patient harm was reported as a result of this occurrence.

• Brand Name: LINESIDER NON-MOD STANDARD TULIP, 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: 14074144
• Report Number: 3012797630-2022-00013
• Device Sequence Number: 6137375
• Product Code: NKB
• UDI-Device Identifier: 00818613027891
• UDI-Public: (01)00818613027891(10)02210131
• 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: 2021
• 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): 04/11/2022

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-N6SA7550
• Device Catalogue Number: LS-N6SA7550
• Device Lot Number: 02210131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2020
• 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 Age: 75 YR
• Patient Sex: Male