MAUDE Adverse Event Report: LIFE SPINE, INC. KINETIC SL; SPINAL FIXATION SYSTEM

Model Number	1283-055
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	01/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the top screw c4 went thru the locking mechnism of the plate.Illiac creast bone graph, patient seems to be on her way to a solid fusion.
Additional Manufacturer Narrative
It was likely the surgeon torqued the screw past the designated diameter that retains the screw within the plate.The distal diameter of the screw hole is tapered in as to retain the screw and indicte to the surgeon that the screw is sufficently inserted.The surgeon may not have identified that the secondary resistance and seemed it was just normal bone resistance, leading to over torquing of the screw that surpassed the retaining ring.

• Brand Name: KINETIC SL
• Common Device Name: SPINAL FIXATION SYSTEM
• Manufacturer (Section D): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer (Section G): LIFE SPINE, INC.; 13951 s. quality drive; huntley IL 60142
• Manufacturer Contact: angela batker ; 13951 south quality drive; huntley, IL 60142 ; 8478846117
• MDR Report Key: 13529590
• Report Number: 3004499989-2022-00002
• Device Sequence Number: 14469005
• Product Code: KWQ
• UDI-Device Identifier: 00190837005405
• UDI-Public: (01)00190837005405
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K073479
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2022

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?: No
• Operator of Device: Other
• Device Model Number: 1283-055
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Female