MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC LINESIDER TULIP 5.5/6.0MM HEAD - 7.1MM BALL - STANDARD; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number LS-TU7S5560

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Based on discussion on 04may2021 with the clinical specialist who was present at the initial procedure, the surgeon had attempted in-situ assembly of the tulips.The tulip associated with this failure, as well as the adjacent screw, was returned to integrity implants.Upon receipt and inspection of the device, including a comprehensive review of the device manufacturing history, it was confirmed that the device was manufactured to design specification.There is evidence to suggest that the surgeon was potentially impeded from mating the tulip and screw shank due to visual or anatomical constraints.

Event Description

It was reported that the patient underwent an initial posterior fixation procedure on (b)(6) 2021.Subsequently, post-operative images, obtained on (b)(6) 2021, revealed dissociation of the linesider standard tulip from the screw shank.A revision procedure was conducted on (b)(6) 2021.

• Brand Name: LINESIDER TULIP 5.5/6.0MM HEAD - 7.1MM BALL - STANDARD
• 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: 11943051
• MDR Text Key: 254509232
• Report Number: 3012797630-2021-00014
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00818613029055
• UDI-Public: (01)00818613029055(10)01200024
• 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: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LS-TU7S5560
• Device Catalogue Number: LS-TU7S5560
• Device Lot Number: 01200024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2020
• 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: 45 YR
• Patient Weight: 120