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

Model Number	LS-TU7S5560
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 6-week post-operative xrays of the patient showed that two tulips were not secured to the screw shanks in a two-level bilateral construct.Immediate post-operative imaging was not available for review.Since the construct is still unilaterally intact at both levels and the patient is doing well, the surgeon and patient have elected not to perform a revision surgery at this time.The surgeon will continue to monitor the patient and if it is determined at a later date that a revision is required, integrity implants will be notified and a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Upon reassessment of the reported event, it was determined that no serious injury was reported as a result of this product malfunction.Additionally, this malfunction has not previously been reported to integrity implants as having caused or contributed to a serious injury on a same/similar device in the past.The initial report was submitted in error and should be voided.
Event or Problem Description
Upon reassessment of the reported event, it was determined that no serious injury was reported as a result of this product malfunction.Additionally, this malfunction has not previously been reported to integrity implants as having caused or contributed to a serious injury on a same/similar device in the past.The initial report was submitted in error and should be voided.

• Brand Name: LINESIDER SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens, fl
• MDR Report Key: 10444571
• Report Number: 3012797630-2020-00004
• Device Sequence Number: 2404031
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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
• 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
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR