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
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• MDR Report Key: 11943051
• Report Number: 3012797630-2021-00014
• Device Sequence Number: 13803668
• Product Code: NKB
• UDI-Device Identifier: 00818613029055
• UDI-Public: (01)00818613029055(10)01200024
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: LS-TU7S5560
• Device Catalogue Number: LS-TU7S5560
• Device Lot Number: 01200024
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 06/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 120