MAUDE Adverse Event Report: INTEGRITY IMPLANTS INC LINESIDER SPINAL SYS NON-MODULAR MIS TULIP 5.5/6.0 DUAL LEAD CANN SCR, 7.5X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	LS-N6MG7545
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	03/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The reported event was confirmed by review of x-rays provided.The complaint sample was returned to integrity implants and evaluated.Visual review identified damage and warping on the threads of the tulip and significant damage to the threads of the set screw.Functional testing of the tulip threads demonstrated inconsistency with the thread form; as the set screw was not able to be seated.Microscopic imaging of the revised set screw threads identified deformation consistent with interference by the inconsistent thread form of the tulip.The device history record was reviewed and no discrepancies relevant to the reported event were found.A review of the complaint history determined that no further action was required as no trends were identified.Investigation results concluded that the root cause of the reported event was due to a manufacturing deficiency.Supplier capa (b)(4) has been initiated to further investigate the deficiency and to document appropriate actions.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Integrity implants will continue to monitor for trends.
Event or Problem Description
It was reported that the patient underwent an initial two-level fixation procedure.Subsequently, the patient was revised three days later due to dissociation of the set screw from the pedicle screw assembly.During the revision procedure, as the surgeon attempted to place a new set screw, it was identified that the threads on the tulip of the assembly were damaged.As a result, he opted to revise the entire pedicle screw construct along the ipsilateral side.The new assemblies and set screws were placed with no issue.No additional patient consequences were reported.

• Brand Name: LINESIDER SPINAL SYS NON-MODULAR MIS TULIP 5.5/6.0 DUAL LEAD CANN SCR, 7.5X45
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): INTEGRITY IMPLANTS INC; 354 hiatt drive; palm beach gardens FL 33418
• MDR Report Key: 11627587
• Report Number: 3012797630-2021-00011
• Device Sequence Number: 14339207
• Product Code: NKB
• UDI-Device Identifier: 00818613026542
• UDI-Public: (01)00818613026542(10)10200064
• 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: 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): 04/07/2021

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-N6MG7545
• Device Catalogue Number: LS-N6MG7545
• Device Lot Number: 10200064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SET SCREW 5.5/ 6.0, TULIP LS-SS255560, 01200028
• Outcome Attributed to Adverse Event: Required Intervention